Senior Process Validation Engineer - GMP Lifecycle Lead

agap2 Switzerland; Bern; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

agap2 Switzerland seeks a Process Validation Engineer to join a European engineering and operational consulting group focused on biotech and pharma projects. You will develop, execute, and maintain validation strategies for GMP manufacturing, collaborating with QA, Engineering, and MSAT to ensure compliant lifecycle management and successful tech transfers.

The ideal candidate holds an engineering degree in biotechnology or life sciences, with 3–5+ years of GMP process validation experience and

Qualifikationen

• Experience with GMP process validation, lifecycle activities, and risk assessments.
• Strong knowledge of EU GMP Annex 15, FDA Process Validation Guidance, ISPE, PIC/S, ICH Q8/Q9/Q10.
• Experience in biotechnology manufacturing processes and equipment validation.

Aufgaben

• Develop, execute, and maintain Process Validation strategies (Stage 1–3) for GMP biotech manufacturing.
• Prepare and review VMPs, IQ/OQ/PQ, PPQ, reports and SOPs.
• Define validation acceptance criteria based on regulatory requirements and QbD principles.
• Coordinate validation campaigns including process performance qualification and sampling strategies.
• Collaborate with Manufacturing, QA, QC, Engineering, and MSAT to ensure compliant lifecycle management.
• Investigate deviations and CAPA related to process validation activities.
• Lead change control affecting validated processes and assess impact.
• Support tech transfer and validation readiness for new products or changes.
• Assist inspections and audits by regulatory authorities and drive continuous improvement.

Kenntnisse

Process Validation

Regulatory Knowledge

Cross-functional Collaboration

Quality by Design

Ausbildung

Engineering degree in Biotechnology/Pharmaceutical Sciences/Chemical Engineering/Life Sciences

Jobbeschreibung

agap2 Switzerland seeks a Process Validation Engineer to join a European engineering and operational consulting group focused on biotech and pharma projects. You will develop, execute, and maintain validation strategies for GMP manufacturing, collaborating with QA, Engineering, and MSAT to ensure compliant lifecycle management and successful tech transfers.

The ideal candidate holds an engineering degree in biotechnology or life sciences, with 3–5+ years of GMP process validation experience and