Senior Validation Specialist

h2 class="font-semibold">Quick Facts

• Role: Senior Validation Specialist (CSV/GxP)

• Work model: Remote or hybrid (2 days/week from the office)

Description

Drive and support validation for GxP computerized systems by defining validation approach, reviewing software documentation and CSV deliverables, and ensuring systems are ready for go-live. Lead validation activities across projects and application maintenance, including audit/inspection preparation, and serve as a CSV subject matter expert for validation-related questions.

Responsibilities

• Determine the validation approach and identify required/impacted deliverables for projects, enhancements, or changes

• Review software documentation per CSV corporate SOPs and regulatory guidance

• Provide estimates and forecasts for validation activities

• Author validation plans/reports; review test plans/reports and other deliverables to assess readiness for go-live

• Coordinate with business quality and informatics quality to ensure compliance with corporate quality policies and standards

• Participate in validation discussions and consult on validation topics

• Review and collect expected CSV deliverables, records, and evidence according to the plan

• Prioritize validation activities according to project schedules, business needs, and compliance requirements

• Ensure code release to production and maintenance procedures are identified and followed

• Confirm initial data loading and/or data migration is performed according to approved procedures

• Assess changes for impact to the validated state of the computerized system

• Support validated-state maintenance and permanent audit readiness

• Follow governance processes and escalate improvement areas

• Support audit/inspection preparation and execution as CSV subject matter expert

• Implement relevant frameworks and processes; propose and use tools

• Provide training and support knowledge exchange in validation/quality

Requirements

• 3+ years’ experience in IT & Software Validation (CSV, GAMP), preferably in a pharma environment

• Mandatory experience in Lean and/or Agile approaches

• Experience leading validation for projects and systems/application maintenance

• Experience authoring validation plans, reports, and deliverable registries

• Experience authoring or reviewing validation deliverables, records, and evidence

• Experience with SDLC processes and pharmaceutical (or other regulated) industry models/standards

• Experience supporting applications under global inspection agencies, CFR 21 FDA Part 11, and Annex 11

• Knowledge of development technologies and governance processes that influence validation approach

• Hands-on experience with Retina or JIRA (backlog management)

• Hands-on experience with ServiceNow (Incident, Change, Knowledge Management)

• English communication skills at C1 level (mandatory)

• Higher education degree or relevant work experience in computer science, software engineering, information systems, and/or pharma industry

• Ability to collaborate in cross-functional teams and communicate clearly (written and verbal)

Benefits

• Flexible working hours

• Stable employment conditions (employment contract or B2B)

• Opportunities for development and promotion

• Attractive benefits package

• Non-corporate atmosphere and challenging projects