PEV Qualification Engineer (m/f/d)
PEV Qualification Engineer (m/f/d)
The Role
- Commissioning, qualification, re‑qualification and periodic review of equipment and systems
- Cleaning, sanitisation and shipping validation, including WTST studies
- Preparation of qualification plans, protocols, reports and risk assessments
- Support of computerised system validation (CSV) activities
- Leading and participating in risk assessments for equipment and systems
- Generation and revision of SOPs aligned with internal standards and global regulations
- Management of deviations, change controls, CAPAs and qualification-related issues
- Ensuring all GMP documentation follows ALCOA++ principles
- Supporting knowledge sharing and training within the validation team
Your Background
- Bachelor's degree in Chemical, Biological or Pharmaceutical Engineering (or similar)
- Minimum 2 years' experience in Commissioning & Qualification (C&Q), validation or engineering within the pharmaceutical or biopharmaceutical industry
- Strong working knowledge of GMP and validation requirements, including:
- EU GMP Annex 11 & Annex 15
- 21 CFR Part 11 / 210 / 211
- GAMP 5, ICH Q9 / Q10
- ISPE Baseline Guidelines and PDA Technical Reports
- Experience with change control, deviations and CAPA management
- Confident working in English (written and verbal)
- Proactive, collaborative and comfortable in a fast‑paced manufacturing environment
Why Apply?
- Join a global biologics organisation with a strong footprint in advanced therapies
- Work in a highly regulated, inspection‑ready environment with world‑class quality standards
- Be part of a diverse, international team focused on changing lives through science
- Gain exposure to complex validation projects in a growing manufacturing network
Apply directly or reach out for a confidential discussion to learn more about the opportunity.
FAQs
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