Are you a detail-oriented and proactive engineer with a passion for ensuring quality and compliance in pharmaceutical manufacturing? We are looking for a Validation Engineer to play a key role in supporting new product introductions, equipment qualification, and site requalification programs. In this role, you will ensure that all equipment, systems, and processes meet cGMP standards and regulatory requirements, contributing directly to the success of our manufacturing operations.
Key responsibilities:
- Design, execute, and report on Process Performance Qualifications (PV/PPQ).
- Conduct validation studies for equipment, systems, and processes.
- Ensure all validation activities comply with Sanofi standards, cGMP, and regulatory requirements.
- Provide technical interpretation and guidance on FDA and EU validation requirements for aseptic processing, sterilisation, depyrogenation, and lyophilisation.
- Maintain validation documentation throughout the lifecycle and ensure equipment and systems remain compliant.
- Support site change control processes and participate in regulatory inspections.
What You Bring:
- 3-5 years’ experience in a healthcare manufacturing environment (pharmaceutical experience preferred).
- Degree in Science (Chemistry, Microbiology, Pharmacy) or Engineering (Chemical, Mechanical, Electrical).
- Strong technical knowledge of pharmaceutical plants, validation, and process development.
- Familiarity with cGMP, GAMP, ISPE, FDA/EU guidelines, and validation standards (AAMI/ANSI, PDA, ISO).
- Excellent problem-solving skills and the ability to troubleshoot validation challenges.
- Proficiency with MS Project, SPC packages, and an understanding of site KPIs is a plus.
