Process Validation Engineer

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.

• Develop, execute, and maintain Cleaning Validation strategies and lifecycle activities for GMP biotechnology manufacturing processes and equipment.
• Prepare and review Cleaning Validation documentation including Validation Master Plans (VMP), protocols, reports, risk assessments, and SOPs.
• Define cleaning acceptance criteria based on regulatory requirements, toxicological assessments, and process/product characteristics.
• Coordinate and support cleaning validation campaigns, sampling activities, and execution on manufacturing equipment and utilities.
• Collaborate cross-functionally with Manufacturing, Quality Assurance, Quality Control, Engineering, and MSAT teams to ensure compliant implementation of cleaning processes.
• Investigate deviations, OOS/OOT results, and implement CAPA related to cleaning validation activities.
• Lead change control activities impacting validated cleaning processes and assess their impact on validation status.
• Support inspections and audits by regulatory authorities and contribute to continuous improvement of the cleaning validation program.
• Ensure compliance with GMP requirements and industry guidelines throughout all validation activities

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