Senior Validation Specialist

Responsibilities

• Determine the validation approach and identify deliverables needed or impacted by projects, enhancements, or changes for GxP computerized systems.
• Review software documentation according to CSV corporate SOPs and regulatory guidance.
• Provide estimates and forecasts for validation activities for projects.
• Author validation plans and reports; review test plans, test reports, and other deliverables to assess and confirm system readiness for go-live.
• Liaise with business quality and informatics quality to ensure compliance with corporate quality policies and standards.
• Participate actively in validation discussions and provide consultancy on validation-related questions.
• Review and collect expected CSV deliverables, records, and other evidence according to plans.
• Prioritize activities in line with 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 from other systems is performed according to approved procedures.
• Assess changes to determine their potential impact on the validated state of computerized systems.
• Support system maintenance to preserve the validated state and permanent audit readiness.
• Observe governance processes and escalate areas for improvement.
• Support system audit and inspection preparation and execution as a CSV subject matter expert.
• Implement relevant frameworks and processes; propose and use tools.
• Provide training and support validation and quality knowledge exchange.

We're looking for you, if you have:

• 3+ years of experience in IT and Software Validation (CSV, GAMP), preferably in a pharma environment.
• Mandatory experience in Lean and/or Agile approaches.
• Experience leading validation for projects and systems maintenance.
• Experience authoring validation plans, reports, and deliverable registries.
• Experience authoring or reviewing validation-related deliverables, records, and other evidence.
• Experience with software development lifecycle processes, models, and standards in the pharmaceutical industry or another regulated environment.
• Experience maintaining and supporting applications under global inspection agencies, CFR 21 FDA Part 11, and Annex 11.
• Awareness of common development technologies and governance processes that impact validation approaches.
• Ability to work collaboratively in cross-functional teams to achieve milestones and goals.
• Clear, professional written and verbal communication skills.
• Ability to share knowledge and guide others.
• Sound decision-making on quality and technical subjects.
• Follow-through and persistence in obtaining input and signatures from globally distributed, busy stakeholders.
• Higher education degree or relevant work experience in Computer Science, Software Engineering, Information Systems, and/or the pharma industry.
• English language proficiency at C1 level.
• Assertiveness, conflict-management, and leadership skills.
• Hands-on experience with Retina or JIRA for backlog management.
• Hands-on experience with ServiceNow for incident, change, and knowledge management.
• Professional Scrum or SAFe certification is an advantage and must be obtained within 6 months after joining.