Fill & Finish GMP Engineer

About the role

agap2 is a European engineering and operational consulting group founded in 2005, working across Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals and Information Technology. As a consultant, you will support clients on site in delivering their projects, adapting quickly to different work environments. Only selected candidates will be contacted for a first exchange.

Key responsibilities

• Drive continuous improvement of the GMP quality system for Fill & Finish, ensuring inspection readiness
• Support batch release by reviewing batch records and manufacturing documentation
• Review and approve GMP documents (SOPs, protocols, reports) for aseptic processes and equipment
• Act as subject matter expert for process validation and equipment qualification (URS, FAT/SAT, IQ/OQ/PQ)
• Lead investigations of deviations, CAPAs, OOS and complaints using a risk-based approach
• Manage change controls affecting processes and systems
• Oversight of aseptic operations (media fills, CCS) and qualification and lifecycle of Fill & Finish equipment (filling lines, isolators, lyophilizers)
• Manage CMO quality oversight and external partner performance
• Contribute to APQR and support audits and inspections as SME

Required profile

• Master's degree in Pharmacy, Engineering, Biotechnology or Quality
• 3-8 years of GMP experience in pharma/biotech
• Strong expertise in Fill & Finish (aseptic processing, sterile manufacturing, equipment qualification)
• Experience in aseptic environments (isolators, cleanrooms, CCS)
• Background in validation/qualification activities
• Fluent in English and German (mandatory)

Required skills

• Good understanding of USP, DSP and Fill & Finish
• Solid knowledge of cGMP (EU GMP, FDA)
• Analytical, communication and stakeholder management skills
• Comfortable in a cross-functional, international environment