Senior Fill & Finish expert GMP

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.

• Drive continuous improvement of the GMP quality system for Fill & Finish
  , ensuring inspection readiness
• Support batch release through rigorous review of batch records and manufacturing documentation
• Review and approve
  GMP documents (
  SOPs, protocols, reports
  ) related to aseptic processes and equipment
• Act as SME for process validation and equipment qualification (
  URS, FAT/SAT, IQ/OQ/PQ
  )
• Lead investigations (
  deviations, CAPAs, OOS, complaints
  ) using a risk-based approach
• Manage change controls impacting processes and systems
• Ensure oversight of aseptic operations (
  media fills, CCS
  )
• Oversee 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

• 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
  )
• Good understanding of USP, DSP, Fill & Finish
• Solid knowledge of cGMP (
  EU GMP, FDA
  )
• Experience in aseptic environments (
  isolators, clean rooms, CCS
  )
• Background in validation/qualification activities
• Strong analytical, communication, and stakeholder management skills
• Comfortable in a cross-functional, international environment
• Fluent in English and German (mandatory)