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 HavesExperience 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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