New offer - be the first one to apply!
July 1, 2026
Principal Scientist, IVD Reagent Development and Manufacturing
Senior
180,000 - 230,004 USD
Palo Alto, CA
DELFI Diagnostics is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI platform is built to address high-burden health challenges. The platform relies on fragmentomics and cell-free DNA (cfDNA) analysis to support early cancer detection.
FirstLook Lung is a laboratory-developed screening test for individuals eligible for lung cancer screening and can be part of routine blood work. The test uses millions of data points to identify individuals who may have cancer detected through low-dose CT, including early stage disease with a negative predictive value of 99.8 percent.
About the role
- Own the IVD reagent development plan execution by developing reagent specifications and manufacturing processes for finished reagents used in molecular diagnostic assays
- Lead the Reagent Development and Operations team and oversee Process Validation and Design Transfer from R&D to Operations
- Define reagent criticality and develop reagent FMEA to support testing rigor and change control requirements
- Develop and qualify QC test methods for reagent lot release, including acceptance criteria and batch record integration
- Evaluate contract reagent manufacturers and support supplier agreements, pilot builds, and quality audits
- Plan reagent stability studies to establish expiry specifications for Verification and Validation activities
- Perform experimental design and data analysis while collaborating with biostatisticians, bioinformaticians, engineers, and scientists
- Develop IVD design documents required for PMA submission under Design Control
Requirements
- PhD with 8+ years or Master’s with 10+ years of industry assay/reagent development experience in Molecular Biology, Biochemistry, Chemistry, or related disciplines
- 3+ years developing IVD diagnostic tests with NGS cfDNA or multi-omic assay technologies under 21 CFR Part 820 or ISO 13485
- 2+ years developing reagent specifications, integrating reagents with automated platforms, and transferring reagent manufacturing processes
- Hands-on experience with IVD or LDT reagent development in regulated GxP laboratory environments
- Experience writing protocols, designing experiments, analyzing data, and documenting results
- Strong collaboration, communication, mentoring, and training experience
- Ability to work on-site in Palo Alto and travel periodically for supplier audits
Preferred
- Experience with IVD reagent kitting and reagent interchangeability
- Experience developing reagent QC methods and process validation workflows
- Experience managing R&D supplier relationships and auditing reagent suppliers
Similar jobs you might like
Technology
New offer

Delfi Diagnostics
Automation Engineer I/II (Contract)
Mid
Palo Alto, CA
48 - 72 USD
🏢 Summary: Role focused on supporting and maintaining high-complexity laboratory automation systems for cancer detection workflows using next-generation sequencing. The position involves troubleshooting liquid handling platforms, supporting instrument validation and regulatory compliance, and collaborating cross-functionally to improve clinical laboratory automation processes. 🗂️ Requirements: B.S. or higher in engineering, biology, or related field, Knowledge of liquid processing equipment in high-throughput settings, Experience with assay automation on liquid handlers, Ability to troubleshoot complex technical problems, Strong technical and non-technical communication skills, Attention to detail and ability to learn new concepts quickly, Comfort working independently and in cross-functional teams, 3+ years of experience developing assay automation on liquid handlers, Experience automating next-generation sequencing workflows, Experience with molecular biology and wet lab techniques, Experience with automation-LIMS integration, Experience designing and executing instrument testing and validation plans, Experience working in regulated laboratory environments 📃 Skills: NGS, Hamilton, Tecan, Beckman, Agilent, LIMS, Sapio, CLIA, CAP, FDA, QMS, cGMP, GXP, cfDNA, IQ, OQ, PQ, PCR, Automation, Fragmentomics 🏢 Description: DELFI Diagnostics, Inc. is developing next-generation blood-based tests for cancer detection using machine-learning methods and whole-genome sequencing data. The DELFI platform leverages fragmentomics and cell-free DNA (cfDNA) analysis to identify cancer through routine blood work. FirstLook Lung is the company’s first laboratory-developed screening test designed for individuals eligible for lung cancer screening. The test uses millions of data points to identify individuals who may have cancer detected through low-dose CT, including early-stage disease. In this role, you will be responsible for supporting high complexity process automation engineering for cancer detection via next generation sequencing. You will troubleshoot, test, and verify automated scripts on liquid handlers while collaborating with clinical laboratory scientists, software engineers, systems engineers, data scientists, and quality teams. The role supports instrumentation development, verification, validation, and deployment into clinical use. What you'll do - Support, maintain, test, and troubleshoot liquid handling platforms (e.g., Hamilton, Tecan, Beckman, or equivalent) used in clinical multi-omics workflows - Perform routine and corrective maintenance on laboratory instruments including liquid handlers, centrifuges, plate sealers, plate peelers, proteomics platforms, thermal cyclers, cold storage units, and related equipment - Monitor and maintain ultra-low temperature (ULT) freezers and refrigerators to ensure sample integrity and compliance - Coordinate instrument qualification activities (IQ/OQ/PQ) and assist with vendor service scheduling - Rapidly diagnose and resolve instrument failures to minimize impact on clinical workflow timelines - Create, execute, and maintain SOPs, maintenance logs, and equipment records in accordance with CAP, CLIA, and NYS DOH laboratory regulations - Accurately document troubleshooting activities, corrective actions, and preventive maintenance in the laboratory quality management system (QMS) - Support gap assessments and readiness activities as the laboratory progresses toward FDA regulation (21 CFR Part 820 / QSR) - Participate in inspections and internal audits; respond to equipment-related observations and corrective action requests - Maintain equipment inventory, calibration schedules, and service records in compliance with regulatory requirements - Collaborate cross-functionally with scientists and lab operations to identify opportunities for process improvement and automation - Support onboarding and training of laboratory staff on instrument operation and maintenance best practices - Assist with reagent and consumable management for instrumentation as needed - Contribute to laboratory needs including assay support, facility tasks, and special projects - Document troubleshooting efforts with root cause analysis and corrective actions under design control and quality management systems - Perform basic lab work in support of R&D activities - Own the Equipment Ticketing System and communicate resolutions and updates to ticket owners - Update instrument status and maintenance completion in LIMS Sapio What you'll bring Required - B.S. or higher in engineering, biology, or related field - Strong analytical ability to solve complex technical problems - Skilled in technical and non-technical communication - Ability to quickly master new concepts and skills with strong attention to detail - Comfortable working independently and in cross-functional team environments Level I - Knowledge of liquid processing equipment and procedures in high-throughput settings - Knowledge of assay automation on liquid handlers such as Hamilton, Agilent, Beckman, and Tecan Level II - 3+ years of experience in assay automation on liquid handlers - Proven experience automating next generation sequencing techniques and procedures in high-throughput settings - Skilled with molecular biology and wet lab techniques including nucleic acid isolation, purification, and quantification - Experience with automation-LIMS integration - Experience designing and executing instrument testing and validation plans Preferred - Knowledge of automating next generation sequencing techniques - Experience with computer programming and programming concepts - Experience working in regulated environments such as CLIA, CAP, NYS, FDA, or GXP - Experience in reagent manufacturing in regulated environments (cGMP) - Experience programming automated liquid handlers for NGS assays, particularly Hamilton An equal opportunity employer. The company values diversity and does not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Healthcare
ASTEK Polska
Senior Java Engineer
Senior
Remote
Wroclaw, DS, Poland
145 - 155 PLN
🏢 Summary: Development of a high-performance molecular diagnostics system based on multiplex PCR, combining backend services and a Swing-based desktop frontend. The role focuses on building and maintaining a modular, automated analyzer platform with strong emphasis on reliability, performance, and code quality. You will work with a modern Java stack and AI-supported development practices in a high-throughput environment. 🗂️ Requirements: Strong experience with Java 17, Experience with Spring 6, Experience with Hibernate 6 or JPA, Experience with relational databases, Knowledge of SQLite, Understanding of Gradle build processes, Experience with Docker, Experience with Liquibase or similar migration tools, Experience with Swing or desktop application development, Use of AI tools in daily development, Ability to work in high-performance, quality-driven environment 📃 Skills: Java, Spring, Hibernate, JPA, SQLite, SQL, Gradle, Docker, Liquibase, Swing, AI, Copilot, ChatGPT 🏢 Description: Additional information: The project focuses on an advanced molecular diagnostics system for infectious diseases, based on multiplex PCR technology, enabling detection of multiple pathogens from a single sample. The solution combines ready-to-use assay cartridges with a modular, automated analyzer featuring a touchscreen interface and robotic cartridge handling. It operates in a high-throughput environment, requiring strong performance, stability, and high-quality code. The role includes both backend development and contribution to a desktop application frontend. The team works with a modern tech stack and actively leverages AI tools to support daily development work. You’re ideal for this role if you: have strong hands-on experience with Java 17, Spring 6, and Hibernate 6 / JPA have experience working with databases (preferably SQLite) are familiar with Gradle and understand build processes have experience with Docker and containerized environments have worked with Liquibase or similar database migration tools have experience with Swing or are willing to work on desktop applications actively use AI tools (e.g., Copilot, ChatGPT) in your daily development work are comfortable working in a high-performance, quality-driven environment Your day-to-day responsibilities include: develop and maintain applications using Java 17 and Spring 6 work on backend components and contribute to the Swing-based frontend integrate with databases and manage schema changes using Liquibase ensure code quality, performance, and system reliability collaborate with the team on designing and implementing new features leverage AI tools to improve development efficiency and solution quality
Healthcare
ASTEK Polska
Senior Java Engineer
Senior
Hybrid
Wrocław, Poland
1,120 - 1,200 PLN
🏢 Summary: Development of a high-performance molecular diagnostics system based on multiplex PCR, combining backend services and a Swing-based desktop application. The role focuses on building and maintaining a modular, automated analyzer platform with strong emphasis on performance, stability, and code quality. Work involves modern Java technologies, database integration, and containerized environments supported by AI-driven development tools. 🗂️ Requirements: Strong experience with Java 17, Experience with Spring 6, Experience with Hibernate 6 or JPA, Experience with databases (preferably SQLite), Knowledge of Gradle and build processes, Experience with Docker and containerized environments, Experience with Liquibase or similar migration tools, Experience with Swing or desktop application development, Use of AI development tools (e.g., Copilot, ChatGPT), Ability to work in high-performance, quality-driven environment 📃 Skills: Java, Spring, Hibernate, JPA, SQLite, Gradle, Docker, Liquibase, Swing, SQL, Git, AI 🏢 Description: Additional information: The project focuses on an advanced molecular diagnostics system for infectious diseases, based on multiplex PCR technology, enabling detection of multiple pathogens from a single sample. The solution combines ready-to-use assay cartridges with a modular, automated analyzer featuring a touchscreen interface and robotic cartridge handling. It operates in a high-throughput environment, requiring strong performance, stability, and high-quality code. The role includes both backend development and contribution to a desktop application frontend. The team works with a modern tech stack and actively leverages AI tools to support daily development work. You’re ideal for this role if you: have strong hands-on experience with Java 17, Spring 6, and Hibernate 6 / JPA have experience working with databases (preferably SQLite) are familiar with Gradle and understand build processes have experience with Docker and containerized environments have worked with Liquibase or similar database migration tools have experience with Swing or are willing to work on desktop applications actively use AI tools (e.g., Copilot, ChatGPT) in your daily development work are comfortable working in a high-performance, quality-driven environment Your day-to-day responsibilities include: develop and maintain applications using Java 17 and Spring 6 work on backend components and contribute to the Swing-based frontend integrate with databases and manage schema changes using Liquibase ensure code quality, performance, and system reliability collaborate with the team on designing and implementing new features leverage AI tools to improve development efficiency and solution quality
Healthcare
Avenga
Senior Java Developer
Senior
Hybrid
Wroclaw, Poland
25,600 - 28,600 PLN
🏢 Summary: Development of software for a high-throughput molecular diagnostics system that detects infectious diseases using multiplex PCR. The role focuses on building and maintaining Java-based applications running on automated laboratory analyzers with robotic cartridge handling. Work involves hybrid collaboration with on-site access to physical diagnostic machines. 🗂️ Requirements: Commercial experience with Java 17, Strong knowledge of Spring v6, Experience with Hibernate v6 or JPA, Experience with SQLite, Experience with Gradle, Experience with Docker, Familiarity with AI agents usage in daily work, Availability for hybrid work in Wrocław with on-site presence when required 📃 Skills: Java, Spring, Hibernate, JPA, SQLite, Gradle, Docker, Swing, Liquibase, AI 🏢 Description: Product: It’s a high-throughput molecular diagnostics system for infectious diseases. Using multiplex PCR (syndromic testing), it can detect multiple pathogens from a single patient sample with minimal hands-on time. The solution combines ready-to-use assay cartridges with a modular, automated analyzer featuring a touchscreen interface and robotic cartridge handling. • java 17 (critical) • spring v6 (critical) • hibernate v6 / jpa (critical) • familiarity with the use of AI agents in everyday work • sqlite db • gradle • swing (big plus) • docker • luqibase Work model: hybrid work (Wrocław) . For these projects, you may need to come into the office more frequently. This software runs on physical machines that will only be available in the office, so you may need to be present at a physical workstation during onboarding and when using key features.
Healthcare

Avalo Therapeutics
Sr. Manager/ Associate Director, Data Management
Senior
On-site
Philadelphia, PA
🏢 Summary: Leadership role overseeing clinical data management across development programs, ensuring high-quality, compliant clinical trial data from study start-up through database lock and regulatory submission. The position drives data strategy, database design, vendor oversight, PK data review, and cross-functional collaboration to support successful clinical and regulatory outcomes. Strong focus on regulatory compliance, inspection readiness, and industry data standards. 🗂️ Requirements: BS/BA in bioscience, engineering, computer science, medical or related field, 6+ years (MS) or 9+ years (BS) clinical data management experience for Senior Manager, 9+ years (MS) or 12+ years (BS) clinical data management experience for Associate Director, Experience leading data management from study start-up through database lock, Strong vendor and CRO oversight experience, Experience supporting regulatory submissions and inspection readiness, Knowledge of ICH-GCP and FDA regulations, Experience with EDC systems (e.g., Medidata Rave) 📃 Skills: EDC, Medidata, Rave, CDISC, CDASH, SDTM, MedDRA, WHODrug, ICH-GCP, FDA, 21CFRPart11, PK, UAT, SOP, GCDMP 🏢 Description: Position Summary: Senior Manager / Associate Director, Clinical Data Management to provide leadership and oversight of clinical data management activities across one or more development programs. This individual is responsible for ensuring the quality, integrity, timeliness, and regulatory compliance of clinical trial data from study start-up through database lock and submission readiness. Working closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Clinical Pharmacology, Pharmacovigilance, Regulatory Affairs, Information Technology, and external partners, this role serves as the Data Management lead for assigned studies and programs, driving data strategy, vendor oversight, process excellence, and inspection readiness. Essential Duties and Responsibilities: Clinical Data Management Leadership - Lead clinical data management activities for assigned studies (especially PK trials) from protocol development through database lock and submission readiness. - Serve as primary point of contact for CROs and vendors, ensuring data delivery on time, within budget, and in compliance with ICH-GCP guidelines. - Represent Data Management on cross-functional study teams, aligning deliverables with study objectives, timelines, and regulatory requirements. - Develop and execute study-specific data management strategies to ensure high-quality, analyzable clinical trial data. - Oversee and maintain Data Management Plans (DMPs), data review plans, and study-level documentation. Database Design, Build, and Validation - Collaborate on design and review of electronic Case Report Forms (eCRFs). - Develop and review database build specifications, edit check specifications, CRF completion guidelines, and validation plans. - Lead User Acceptance Testing (UAT) and oversee database go-live readiness. - Ensure databases are designed and validated in accordance with protocol requirements, CDASH standards, and best practices. Data Review and Quality Oversight - Lead ongoing PK and clinical data review, discrepancy management, query generation, and resolution. - Establish and monitor data quality metrics to ensure accuracy, consistency, completeness, and analysis readiness. - Oversee reconciliation activities including SAEs, laboratory data, medical coding, protocol deviations, and external data sources. - Manage MedDRA and WHODrug coding activities. - Support database lock activities and final data transfers for statistical analysis and regulatory submissions. Vendor and CRO Management - Manage bioanalytical vendors for PK assays and ensure appropriate data collection. - Provide oversight of CROs, EDC providers, specialty laboratories, and other external vendors. - Participate in vendor selection, RFP reviews, and vendor assessments. - Review vendor contracts, data transfer agreements, and service deliverables. - Monitor vendor performance, timelines, quality metrics, and issue resolution. Cross-Functional Collaboration - Partner with Biostatistics and Statistical Programming to support data review, SAP development, listings review, and submission readiness. - Collaborate with Clinical Operations, Clinical Pharmacology, Safety, Regulatory Affairs, and Medical teams to ensure accurate data collection and reporting. - Provide data management updates, risk assessments, and recommendations in study team meetings. - Support preparation and review of clinical study reports, tables, listings, and regulatory submission deliverables. Process Improvement and Compliance - Contribute to development and continuous improvement of Data Management processes, SOPs, standards, and best practices. - Ensure compliance with ICH-GCP, FDA regulations, CDISC/CDASH standards, GCDMP guidelines, and company procedures. - Support inspection readiness and participate in regulatory inspections and audits. - Mentor junior team members and contribute to team development. Required Education and Experience: - BS/BA in bioscience, engineering, computer science, medical training, or related field; MS/MA preferred. - Senior Manager: 6+ years (MS/MA) or 9+ years (BS/BA) of clinical data management experience in biotechnology, pharmaceutical, or CRO industry. - Associate Director: 9+ years (MS/MA) or 12+ years (BS/BA) of clinical data management experience in biotechnology, pharmaceutical, or CRO industry. - Experience leading data management from study start-up through database lock. - Strong vendor and CRO oversight experience. - Experience supporting regulatory submissions and inspection readiness. Preferred: - Management of PK trial data and clinical pharmacology experience. Additional Skills, Knowledge, and Abilities: - Deep understanding of clinical data management principles and industry standards. - Working knowledge of ICH-GCP, FDA regulations, 21 CFR Part 11, CDISC/CDASH, SDTM, MedDRA, and WHODrug. - Experience with EDC systems such as Medidata Rave or equivalent. - Experience with drug development and PK sample collection. - Strong understanding of external data integrations, reconciliation processes, and database lock procedures. - Strong project management, organizational, and problem-solving skills. - Ability to manage multiple priorities in a fast-paced environment.
Healthcare
KUBO
Java Developer
Mid
Hybrid
Wroclaw, Poland
130 - 150 PLN/hr
🏢 Summary: The offer is for a Java Developer responsible for designing and developing backend solutions for genetic diagnostics and analytical software within an international Scrum team. The role involves system and API integration, database work, and maintaining software quality in a biotechnology environment. It is a hybrid B2B position based in Wrocław. 🗂️ Requirements: Minimum 4 years of experience as Java Developer, Experience with Java 17, Experience with Spring 6, Experience with Hibernate 6 or JPA, Experience with Angular, Experience with PostgreSQL, Experience with Gradle, Experience with Docker, Ability to work in Scrum/Agile environment, English level minimum B2 📃 Skills: Java, Spring, Hibernate, JPA, Angular, PostgreSQL, Gradle, Docker, Scrum, Agile 🏢 Description: For our client we are currently looking for a Java Developer who, together with the team, will be responsible for the technical aspects of the project related to genetic diagnostics. In this position you’ll collaborate with a team from Poland and German and be a part of global company in the field of biotechnology and molecular diagnostics. Key responsibilities Designing and developing backend solutions in Java Working in a Scrum/Agile team System and API integration Working with databases Developing diagnostic and analytical software Participating in testing and quality maintenance Working in an international environment Ideal candidate profile Minimum 4 years of experience in a similar position Experience with Java minimum 17 (required) Spring version 6 and Hibernate 6 / JPA (required) Experience with Swing Experience using Gradle Knowledge of Docker English language: minimum B2 Nice to have: experience with unit testing and AI tools Conditions Location: hybrid in Wrocław, Poland (Initially 2–3 days/week in the office, with the possibility to reduce to 1 day/week later) Contract type: B2B Salary: 130-150 PLN/h + VAT Benefits: Private medical care, life insurance, Multisport card Recruitment steps Phone call with a Recruiter (approx. 30 min.) Interview with Client (1,5h) Decision and feedback
Technology
Link Group
Mendix Test Engineer
Mid
Remote
Poznan, Poland
100 - 110 PLN
🏢 Summary: The offer is for a Software Tester responsible for ensuring quality and compliance of Mendix applications in a regulated pharmaceutical environment. The role focuses on functional, regression, and integration testing, defect management, and validation documentation in line with GxP standards. The position requires close collaboration with cross-functional teams to maintain high-quality low-code solutions. 🗂️ Requirements: Experience in software testing, Experience with Mendix or low-code platforms, Knowledge of testing methodologies and best practices, Familiarity with GxP and pharmaceutical validation processes, Ability to create and maintain test documentation, Defect tracking and management skills, Good command of English 📃 Skills: Mendix, Testing, Regression, Integration, GxP, Validation, Lowcode, Documentation, English 🏢 Description: Responsibilities Design, execute, and maintain test cases for Mendix applications (functional, regression, and integration testing). Ensure application quality and compliance with pharmaceutical industry standards and validation requirements. Collaborate closely with developers, business analysts, and product owners to clarify requirements and acceptance criteria. Identify, document, and track defects through to resolution. Support test documentation and validation activities required in regulated environments (e.g. GxP). Requirements Experience in software testing, preferably with Mendix or low-code platforms . Knowledge of testing methodologies, tools, and best practices. Familiarity with validation and quality processes in pharmaceutical or life sciences projects. Attention to detail and strong analytical skills. Good command of English, both written and spoken.
Healthcare
Bayer Sp. z o.o.
Senior Product Specialist
Senior
Hybrid
Warsaw, Poland
20,240 - 25,300 PLN
🏢 Summary: The role focuses on ensuring GxP‑regulated digital systems, particularly LIMS and connected laboratory platforms, remain validated, compliant, and fit for purpose throughout their lifecycle. It combines hands‑on CSV validation, data integrity oversight, and system integration control with product ownership and stakeholder collaboration in Agile/DevOps environments. The position supports global validation, user adoption, and continuous improvement of regulated laboratory systems. 🗂️ Requirements: Bachelor’s or Master’s degree in Computer Science, Engineering or related field, Minimum 5 years of experience in product specialist or validation roles, Strong experience with GxP / CSV validation of laboratory or scientific software, Hands-on experience with ValGenesis and/or Azure DevOps, Knowledge of software development lifecycle in Agile/DevOps environments, Experience with validation lifecycle activities (IQ, OQ, PQ), Understanding of data integrity principles (ALCOA+), Experience validating system integrations and interfaces, Knowledge of role-based access control and electronic records/signatures compliance 📃 Skills: GxP, CSV, LIMS, SDMS, SAP, ValGenesis, Azure, DevOps, ALCOA+, IQ, OQ, PQ, ERP, Agile, RBAC 🏢 Description: At Bayer, we are committed to transparency, equal pay for equal work or work of equal value, and objective reward practices in line with EU and local regulations. The minimum annual gross compensation for this role is 20 240 PLN , with final pay determined based on objective factors such as experience, qualifications, scope of responsibility, and internal alignment. This position is eligible for variable pay components , such as performance‑based bonuses, awarded in accordance with the applicable employee group, role scope, and compensation structure. In addition, Bayer offers a competitive and holistic benefits package, including: - Medical care above statutory requirements - Flexible benefits supporting leisure, and well‑being/sports programs - Life, accident, and disability insurance through group coverage - Employer‑supported pension plans with regular company contributions - Home office allowance to support hybrid or remote work - Extra Paid Holidays Benefits may vary depending on country, role, and employment conditions. For Digital Hub Warsaw, we are looking for: Senior Product Specialist: As a Senior Product Specialist, you will ensure regulated digital products remain compliant, validated, and user-friendly throughout their lifecycle. You will combine GxP validation expertise, product enablement, and stakeholder collaboration to deliver high-quality solutions, particularly across LIMS and connected laboratory systems. YOUR TASKS AND RESPONSIBILITIES Validation & Compliance Lead GxP validation activities across the full system lifecycle (implementation → decommissioning). Plan and oversee IQ/OQ/PQ, ensuring systems remain in a validated state in Agile/DevOps environments. Manage validation deliverables (plans, risk assessments, testing, deviations, change control). Ensure data integrity (ALCOA+), audit trails, e-signatures, and access controls. Validate integrations with LIMS, SDMS, instruments, and ERP/SAP. Act as SME for validation and compliance topics . Product Adoption & Collaboration Drive user adoption through training, communication, and documentation. Align stakeholders across business, quality, and engineering. Coordinate UAT, acceptance criteria, and release readiness. Translate technical and compliance topics for diverse audiences. Use feedback and metrics to improve product performance and user experience . Leadership & Delivery Lead cross-functional initiatives and validation workstreams. Manage timelines, risks, and dependencies. Support continuous improvement and mentor junior team members. WHO YOU ARE: Required Qualifications Bachelor’s or Master’s degree in Computer Science, Engineering, Life Sciences, or related field. 5–7+ years of experience in product specialization, validation, or similar roles in regulated environments. Strong hands-on experience in GxP / CSV validation of scientific or laboratory software. Proven experience with validation tools such as ValGenesis and/or Azure DevOps. Strong understanding of software development lifecycle (SDLC) and Agile/DevOps methodologies. Demonstrated ability to lead cross-functional initiatives and manage complex projects. Excellent communication, stakeholder management, and influencing skills. Preferred Qualifications Experience with LIMS, SDMS, or SAP in regulated laboratory environments. Exposure to product development, backlog management, or product ownership concepts. Formal project management experience or certification. Experience working in global, multi-regional, or multi-platform environments. Ability to influence without formal authority and navigate complex stakeholder landscapes Please send your CV in English.
Technology
DPDgroup IT Solutions
Manual Tester
Mid
Hybrid
Warsaw, Poland
9,000 - 11,000 PLN/mo
🏢 Summary: The offer is for a Manual Tester responsible for ensuring quality across project deliveries by performing functional and exploratory testing, validating UI and backend solutions, and supporting release readiness. The role covers the full testing lifecycle, including test design, execution, defect investigation, and collaboration within Agile teams. The tester also contributes to risk identification and supports test automation processes from a governance perspective. 🗂️ Requirements: 2–4 years of experience in manual QA or software testing, Strong functional testing skills, Strong exploratory testing skills, Ability to write clear test cases, Ability to create clear and reproducible defect reports, Experience with Jira and Zephyr or similar tools, Basic to intermediate SQL knowledge, Understanding of SDLC, Understanding of Agile/Scrum, Ability to identify and communicate risks early 📃 Skills: QA, Testing, FunctionalTesting, ExploratoryTesting, SQL, Jira, Zephyr, SDLC, Agile, Scrum, Postman, API 🏢 Description: We are looking for a Tester to strengthen quality across DGITS delivery projects. This role focuses on testing business and product solutions delivered by one of our projects. The tester contributes across the lifecycle: from refinement and test design, through execution and defect investigation, to release readiness and quality risk visibility. Key Responsibilities: Test features, integrations, and end-to-end flows across DGITS projects Design and execute functional tests based on requirements, acceptance criteria, risks, and dependencies Perform exploratory testing to uncover gaps, edge cases, and integration risks Validate quality across UI and backend, using SQL where needed Investigate defects and create clear, reproducible defect reports Maintain test cases and traceability in Jira/Zephyr or similar tools Identify missing information, testability gaps, and quality risks early Support release readiness by highlighting risks, coverage gaps, and known issues Collaborate with developers, BAs, POs, and PMs to improve delivery quality Support test automation process from design and governance perspective Required skills and experience: 2–4 years of experience in manual QA / software testing Strong functional and exploratory testing skills Ability to write clear test cases and defect reports Practical experience with Jira and Zephyr or similar tools Basic to intermediate SQL for validation and investigation Understanding of SDLC and Agile/Scrum Ability to identify and communicate risks early Strong quality ownership and collaboration skills Nice to have: API testing experience, e.g. Postman Experience with integrations or data-driven workflows Experience contributing to release readiness or go/no-go decisions Practical use of AI tools to support QA work, with proper validation We offer you: Salary: 9 000 - 11 000 PLN net/B2B (depends on experience) Work-life balance: hybrid service delivery model (2 times per week in the office) Semi-annual evaluation meetings and a clearly defined career path A friendly Buddy to guide you through the onboarding and further training and career opportunities Training possibilities for personal development after completing the onboarding period Space to implement your own ideas Other amenities, such as: Fitness card (Benefit Multisport) Private health care (EnelMed) An open and casual company culture filled with internal events The opportunity to quickly develop professionally on projects in Europe and all over the world Great integration events :) Referral Program How our recruitment process looks like: Interview with our recruiter (around 30 minutes) - online Technical interview withTeam Lead (around 1 hour) - online Open Day - Meeting at our office (will last about 4 hours
Technology

Blue Sky Innovators
Data Engineer, TS/SCI
Senior
On-site
Reston, VA
🏢 Summary: Lead Data Engineer serving as an SME to design, implement, and sustain secure, automated data pipelines supporting mission systems across a government software ecosystem. The role focuses on building scalable ETL workflows, defining data exchange interfaces, and ensuring interoperability and RMF compliance in highly regulated environments. You will enable reliable ingestion, transformation, and dissemination of mission-critical data across internal and external systems. 🗂️ Requirements: Bachelor’s degree with 9+ years of experience or Master’s with 7+ years or PhD/JD with 4+ years in relevant field, 7+ years experience in software engineering, systems integration, or platform implementation in DoD, IC, SAP/SCI, or similar environments, Experience designing or implementing data pipelines, ETL workflows, or data integration architectures, Experience with structured and semi-structured data formats, Active Top Secret clearance with ability to obtain SCI and Special Program access, Willingness to undergo polygraph examination 📃 Skills: Python, ETL, JSON, CSV, XML, Apache, NiFi, Airflow, Pandas, NumPy, REST, RMF, PPSM, Palantir, Foundry 🏢 Description: Job Description Seeking a Lead Data Engineer / Mission Data Pipeline to serve as a Subject Matter Expert (SME). You will work directly with government, technical, and industry stakeholders design, implement, and sustain data pipelines that ingest, transform, store, and distribute mission-relevant data across the DIFC2 software ecosystem and external mission partner systems/ You will support the development and delivery of software capabilities that improve data accessibility, mission integration, operational visibility, and cross-system interoperability across a highly dynamic mission environment. The focuses on enabling reliable, automated, and secure data flows that support mission capabilities on operational timelines. This position requires collaboration with mission system stakeholders, platform engineers, and security teams to define data exchange artifacts, develop pipeline implementations, and ensure interfaces comply with Risk Management Framework (RMF) requirements. The engineer will leverage both low-code/no-code ETL technologies and custom software development to implement scalable data pipelines that support the data architecture. Typical job responsibilities Include: Mission-Relevant Data Artifact Identification: Analyze mission workflows and system architecture to identify the data artifacts required to support operational capabilities. Define the structure, semantics, and lifecycle of mission data products within the data architecture. Ensure data artifacts align with architectural standards for interoperability, traceability, and reuse across mission components. Coordinate with External Stakeholders: Serve as the primary technical liaison for defining data exchange interfaces between mission systems. Collaborate with mission partners to define message schemas, data formats, transport mechanisms, and interface expectations. Document data interface specifications to support both system integration and operational sustainment. RMF & Security Documentation Support: Support the RMF process by defining technical details for machine-to-machine data interfaces. Produce or contribute to required RMF artifacts including: Data message descriptions Ports, Protocols, and Services Management (PPSM) entries System topology diagrams and interface documentation Coordinate with cybersecurity engineers to ensure pipeline implementations meet DoW security and compliance requirements. Data Pipeline Development & Sustainment: Design and implement automated data pipelines that ingest, transform, persist, and expose data artifacts for use by internal and external stakeholders. Utilize government-provided data platform infrastructure to build scalable ETL workflows. Develop custom transformation logic when required using appropriate programming languages and data processing frameworks. Expose processed data products through standardized service interfaces such as REST APIs or platform-native services. Data Pipeline Development & Sustainment: Implement data validation, normalization, and transformation logic to ensure accuracy and usability of integrated datasets. Troubleshoot data pipeline failures and implement monitoring, logging, and recovery mechanisms. Optimize pipeline performance to support mission timelines and large-scale data processing requirements. Deliverables & Key Projects Design and implementation of production data pipelines enabling automated ingestion and dissemination of mission data across systems. Technical documentation describing data artifacts, including purpose and operational relevance, source systems and ingestion methods, transformation logic, and destination systems and access interfaces Interface documentation supporting integration with external mission partners. RMF technical artifacts supporting security authorization of data interfaces. Continuous improvement and sustainment of the data pipeline ecosystem to support evolving mission needs. Qualifications 9 years of experience and a Bachelor's degree in Computer Science, Software Engineering, Management Information Systems/Information Systems, or a related discipline; or a Master's degree and 7 years of experience; or a PhD/JD and 4 years of experience. 7+ years of experience supporting software engineering, systems integration, platform implementation, or application development efforts within DoD, IC, SAP/SCI, or other complex mission environments. Experience designing or implementing data pipelines, ETL workflows, or data integration architectures. Experience working with structured and semi-structured data formats (JSON, CSV, XML, etc.). Requires an active Top Secret clearance with the ability to obtain and maintain Sensitive Compartmented Information and Special Program access, as well as a willingness to consent to a polygraph examination. You will wow us even more if you have experience will the following: Proficiency with low-code/no-code data orchestration technologies such as Apache NiFi, Apache Airflow, or similar ETL orchestration tools. Experience implementing data transformation logic using Python and data processing libraries such as Pandas and NumPy. Certification or demonstrated experience as a Palantir Foundry Data Engineer, including use of Code Repositories, Pipeline Builder, AIP Logic, and other platform-relevant technologies Experience designing pipelines that process and fuse large-scale datasets from multiple sources. Familiarity with DoW data architectures, mission system integration, or data interoperability frameworks. Ability to communicate effectively with engineers, architects, operators, and senior Government leadership while translating technical concepts into mission-relevant value. Proven ability to work in highly regulated, fast-moving environments where technical excellence, mission responsiveness, and stakeholder coordination are all critical to success. Blue Sky Innovators, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. If you are a qualified job seeker with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access http://www.blueskyinnovators.com as a result of your disability. To request an accommodation, please email us at careers@blueskyinnovators.com and provide your name and contact information. Please note: this is only for job seekers with disabilities requesting an accommodation.