Senior Process Engineer

Our client, a leader in the pharmaceutical sector, is seeking a Filling Engineer to lead process engineering for a bulk filling system on a new production line. This role oversees the system from concept through qualification, ensuring equipment, utilities, and automation function as a single GMP-compliant unit. The position involves producing technical documentation, managing vendor deliverables, and maintaining project timelines.

• Develop User Requirement Specifications (URS), Equipment Requirement Specifications (ERS), and Functional Specifications for filling systems and clean utilities.
• Produce process documentation including Process Flow Diagrams, P&IDs, and instrument lists.
• Define cleaning concepts (CIP/SIP), single-use strategies, and containment requirements for the filling area.
• Manage equipment procurement packages and coordinate with vendors throughout design, fabrication, and FAT.
• Lead process safety and risk assessments, including HAZOP, Sensor Risk Assessments (SRA), and FMEA.
• Coordinate with automation and HVAC teams to align system boundaries and cleanroom classification requirements.
• Support commissioning and qualification by reviewing FAT/SAT specifications and witnessing site testing.

• Master's in Chemical, Process, Mechanical, Biotech, or Pharmaceutical Engineering.
• You have 5+ years of process engineering experience in the pharmaceutical or biotech industry, specifically with bulk filling or aseptic processing.
• You bring solid knowledge of GMP, GAMP 5, EU Annex 1, and regulatory expectations for drug product handling.
• You possess experience writing URS, FS, ERS, and P&IDs while steering vendors through technical specifications.
• You have working knowledge of CIP/SIP, single-use systems, and clean utility design including WFI and clean steam.
• You're familiar with commissioning and qualification (C&Q) deliverables such as SIA, traceability matrices, and FAT/SAT protocols.
• You are fluent in English.

Nice to Haves

• Experience with COMOS or other integrated engineering platforms.
• Familiarity with PED, ATEX, Ex zoning, and high-potency product containment.
• Knowledge of Dutch, French, or German.

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