Process Validation Engineer

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 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.

As a consultant, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills.

You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what’s behind closed doors of the biggest projects of our client’s portfolio.

Responsibilities

• Develop, execute, and maintain Process Validation strategies and lifecycle activities (Stage 1–3: Process Design, Process Qualification, and Continued Process Verification) for GMP biotechnology manufacturing processes and equipment.
• Prepare and review Process Validation documentation including Validation Master Plans (VMP), protocols (IQ/OQ/PQ, PPQ), reports, risk assessments, and SOPs.
• Define validation acceptance criteria based on regulatory requirements, product/process characterization data, and Quality by Design (QbD) principles.
• Coordinate and support validation campaigns, including process performance qualification, sampling strategies, and execution on manufacturing equipment, utilities, and facilities.
• Collaborate cross-functionally with Manufacturing, Quality Assurance, Quality Control, Engineering, and MSAT teams to ensure compliant implementation and lifecycle management of validated processes.
• Investigate deviations, OOS/OOT results, and process excursions, and implement CAPA related to process validation activities.
• Lead change control activities impacting validated processes and assess their impact on the overall validation status.
• Support technology transfer activities and ensure validation readiness for new products, processes, or facility changes.
• Support inspections and audits by regulatory authorities and contribute to continuous improvement of the process validation program.
• Ensure compliance with GMP requirements and industry guidelines throughout all validation activities.

Your profile

• Engineering degree in Biotechnology, Pharmaceutical Sciences, Chemical Engineering, Life Sciences, or a related field.
• 3–5+ years of experience in Process Validation within a GMP-regulated biotechnology, pharmaceutical, or life sciences environment.
• Strong knowledge of GMP regulations and industry guidelines related to Process Validation (EU GMP Annex 15, FDA Process Validation Guidance, ISPE, PIC/S, ICH Q8/Q9/Q10).
• Experience with biotechnology manufacturing processes (upstream/downstream), process characterization, and validation of equipment, utilities, and facilities.
• Fluency in English is mandatory; German is considered a strong advantage.