Overview
As a CQV Engineer at Amgen, you support validation strategies across pharmaceutical manufacturing, ensuring equipment, systems and processes are commissioned, qualified, and validated in GMP-compliant ways. You collaborate with engineering, quality, and project teams to deliver CQV milestones and provide technical guidance. You will shape validation deliverables and risk-based decisions in a highly regulated environment. This role offers meaningful impact by enabling compliant, efficient project execution and robust technical solutions.
Verantwoordelijkheden
- Develop and maintain validation lifecycle documentation (System Criticality Assessments, CQV Plans, Risk Assessments, Test Protocols, Requirements Traceability Matrices, Validation Summary Reports)
- Lead commissioning, qualification and validation activities and document results
- Deliver CQV project milestones and provide technical guidance to project teams
- Support issue resolution and risk management throughout execution
- Ensure alignment of documentation with GMP requirements and internal SOPs
Belangrijkste vereisten
- Minimum 3 years of CQV experience in pharmaceutical manufacturing
- Hands-on experience with Secondary Packaging Systems
- Experience with Print & Inspection Systems (Systech, Cognex)
- Experience with Computerised Systems Validation (CSV)
- Strong GMP knowledge and experience executing CQV activities
- Strong technical documentation skills
- Independent with minimal supervision
- Excellent written and verbal communication
- Customer and stakeholder management
- CQV planning and execution
- Documentation and technical writing
- Risk assessment and validation planning
(CQV) Engineer in Breda werkgever: Jobrapido
StarPark is een uitstekende werkgever die je de kans biedt om te werken op diverse evenementen en festivals, waar je in een informele en prettige werksfeer kunt bijdragen aan de veiligheid van bezoekers. Met flexibele werkmogelijkheden en goede begeleiding vanuit het team, stimuleert StarPark persoonlijke groei en ontwikkeling, waardoor je niet alleen waardevolle ervaring opdoet, maar ook de mogelijkheid hebt om door te groeien binnen de organisatie. Wij verwelkomen iedereen, ongeacht achtergrond, en geloven dat jouw talent het belangrijkste is.
