Senior Process Engineer – Fill & Finish (Pharma)

About the role

This position bridges engineering, validation and production to ensure reliable, compliant start‑up and ongoing performance of complex aseptic equipment. You will be accountable for high equipment availability and optimal OEE from day one in a fast‑paced pharmaceutical environment.

Key responsibilities

• Act as the single technical authority for fill‑and‑finish systems, including isolators, filling lines, freeze dryers, inspection and packaging equipment.
• Lead the integration of CAPEX projects into active operations, overseeing qualification, validation and hand‑over to routine GMP production.
• Establish and maintain technical systems that drive maintenance efficiency, performance optimisation, standardisation and digitalisation.
• Coordinate cross‑functional projects within a matrix structure, working closely with Production, QA, CQV, Warehouse, Tech Support, MSAT and QC.
• Manage deviations, CAPAs and change controls while ensuring inspection readiness and strict compliance with EU GMP Annex 1 and other global standards.

Required profile

• Degree in Engineering, Pharmaceutical Technology, Biotechnology or a related technical field.
• Extensive experience in pharma operations engineering, specifically aseptic Fill & Finish processes and complex equipment.
• Proven track record in technical project management and transitioning large‑scale CAPEX projects into routine GMP operations.
• Fluency in English and German.

Required skills

• Aseptic Fill & Finish processes
• Complex equipment (isolators, filling lines, freeze dryers)
• CAPEX project integration
• Qualification and validation
• GMP compliance (EU GMP Annex 1)
• Technical project management