Process Validation Engineer

agap2 Switzerland; Bern; Vor Ort; CHF 110.000 - 160.000; Vollzeit

Zusammenfassung

agap2 is a European engineering and operational consulting group. We are looking for a Process Validation Specialist to support our clients on site, bringing expertise in GMP biotechnology manufacturing and lifecycle activities.

You will develop, review, and execute validation strategies, collaborate with Manufacturing, QA, and Engineering, investigate deviations, and ensure readiness for inspections while contributing to continuous improvement of the validation program.

Qualifikationen

• 3–5+ years of experience in Process Validation within GMP biotechnology/pharma environments.
• Strong knowledge of GMP regulations and industry guidelines relevant to Process Validation (EU GMP Annex 15, FDA guidance, ISPE, PIC/S, ICH Q8/Q9/Q10).
• Experience with biotechnology manufacturing processes and validation of equipment, utilities, and facilities.

Aufgaben

• Develop, execute, and maintain Process Validation strategies and lifecycle activities for GMP biotech processes and equipment.
• Prepare and review Validation Master Plans, IQ/OQ/PQ, PPQ, protocols, reports, risk assessments, and SOPs.
• Coordinate and support validation campaigns, sampling strategies, and execution on manufacturing equipment, utilities, and facilities.
• Collaborate with Manufacturing, QA, QC, Engineering, and MSAT teams to ensure compliant implementation and lifecycle management of validated processes.
• Investigate deviations, OOS/OOT results, and CAPA related to process validation activities.
• Lead change control activities impacting validated processes and assess their impact on validation status.
• Support technology transfer activities and validation readiness for new products, processes, or facility changes.
• Support inspections and audits by regulatory authorities and contribute to continuous improvement of the validation program.
• Ensure compliance with GMP requirements and industry guidelines throughout validation activities.

Kenntnisse

Process Validation

GMP knowledge

Cross-functional collaboration

English fluent

German helpful

Ausbildung

Engineering degree in Biotechnology or related field

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 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.