Process engineer - Aseptic filling

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.Process Engineer – Aseptic FillingOverviewWe are seeking an experienced Process Engineer to support Performance Qualification (PQ) activities for aseptic filling lines in sterile pharmaceutical manufacturing. The successful candidate will ensure that filling equipment and associated systems meet performance, quality, and regulatory expectations, contributing to the qualification of robust aseptic production processes.Key ResponsibilitiesPlan, coordinate, and execute Performance Qualification (PQ) activities for liquid and vial filling lines and related systems (isolators, conveyors, cappers, etc.).Define PQ strategy, acceptance criteria, and test plans in alignment with project validation master plans and GMP requirements.Perform PQ testing to verify equipment functionality, process stability, and reproducibility under simulated production conditions.Collaborate closely with engineering, quality assurance, validation, and production teams to ensure timely and compliant PQ execution.Review and approve PQ protocols, deviations, and summary reports.Support troubleshooting and ensure timely resolution of qualification-related issues.Ensure all PQ activities comply with GMP, FDA, EMA, and EU GMP Annex 1 requirements.Contribute to process validation readiness, ensuring equipment qualification supports aseptic process integrity and upcoming media fill execution.QualificationsBachelor’s or Master’s degree in Engineering, Biotechnology, Pharmacy, or related field.Minimum 3–5 years of experience in equipment qualification or process validation within pharmaceutical aseptic manufacturing.Proven expertise in Performance Qualification (PQ) of filling equipment (liquid and vial filling).Strong understanding of aseptic processing principles, cleanroom operation, and contamination control.Experience with media fills (aseptic process simulation) and process validation is a significant advantage.Familiarity with Annex 1, GAMP 5, ASTM E2500, and related validation standards.Fluent in both German and English (written and spoken) — essential for effective communication and documentation.Excellent technical writing, analytical, and interpersonal skills.Preferred SkillsExperience with automated aseptic filling technologies and isolator-based systems.Understanding of critical process parameters (CPPs) and their linkage to equipment performance and process control.Prior participation in tech transfer, facility start-up, or qualification projects.