Assignment Description
We are looking for an experienced Validation Lead
What You Will Work On
- Define and lead the overall validation strategy for the project
- Develop verification and qualification approaches for technical systems and equipment
- Lead validation activities across project phases
- Perform and coordinate risk assessments related to validation
- Ensure full compliance with GMP and GxP regulations
- Lead Computerized System Validation (CSV) activities
- Validate computerized systems, manufacturing processes, and technical equipment
- Support validation of DeltaV or similar automation platforms
- Develop and maintain traceability matrices
- Coordinate qualification activities including IQ, OQ, and related verification processes
- Manage validation documentation and compliance deliverables
- Lead deviation investigations, CAPA activities, and corrective actions
- Collaborate with automation, process, commissioning, engineering, and quality teams
- Coordinate validation activities across multiple stakeholders
- Ensure successful delivery of validation objectives within project timelines
What You Bring
- Several years of validation experience within the pharmaceutical industry
- Strong knowledge of GMP and GxP regulatory requirements
- Extensive experience with Computerized System Validation (CSV)
- Experience validating computerized systems, manufacturing processes, and technical equipment
- Practical experience with DeltaV or similar automation platforms in regulated environments
- Experience developing validation strategies and verification approaches
- Experience conducting risk assessments and qualification planning
- Experience with traceability matrices and requirements management
- Experience handling deviations, CAPA, and validation documentation
- Strong leadership, coordination, and stakeholder management skills
- Excellent communication and technical documentation skills
If this sounds interesting, please send your CV to cv@veritaz.se
