Process Validation Engineer

About the role

agap2 is seeking a Process Validation Engineer to join its consultancy team and support clients in the biotechnology and pharmaceutical sectors. You will work on‑site with customer teams, applying your expertise in cleaning validation to ensure manufacturing processes meet strict GMP standards.

Key responsibilities

• Develop, execute and maintain cleaning validation strategies for GMP‑regulated biotechnology manufacturing processes and equipment.
• Prepare and review validation documentation, including Validation Master Plans, protocols, reports, risk assessments and SOPs.
• Define cleaning acceptance criteria based on regulatory requirements, toxicological assessments and product characteristics.
• Coordinate cleaning validation campaigns, sampling activities and execution on manufacturing equipment and utilities.
• Collaborate with Manufacturing, QA, QC, Engineering and MSAT teams to ensure compliant implementation of cleaning processes.
• Investigate deviations, OOS/OOT results and implement CAPA related to cleaning validation.
• Lead change‑control activities affecting validated cleaning processes and assess impact on validation status.
• Support regulatory inspections and audits and drive continuous improvement of the cleaning validation program.

Required profile

• Engineering degree in Biotechnology, Pharmaceutical Sciences, Chemical Engineering, Life Sciences or related field.
• 3–5+ years of experience in cleaning validation within a GMP‑regulated biotech, pharma or life‑sciences environment.
• Strong knowledge of GMP regulations and industry guidelines (EU GMP, FDA, ISPE, PIC/S).
• Experience with biotechnology manufacturing processes and cleaning technologies for equipment and utilities.
• Excellent communication and stakeholder‑management skills in cross‑functional, international teams.
• Fluency in English; German is a strong advantage.

Required skills

• Cleaning Validation
• GMP regulations (EU GMP, FDA, ISPE, PIC/S)
• Risk assessment
• CAPA implementation
• Validation Master Plan development
• SOP creation and review
• Sampling techniques for equipment cleaning
• Process equipment cleaning technologies