PpOur 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. /pbrulliDevelop User Requirement Specifications (URS), Equipment Requirement Specifications (ERS), and Functional Specifications for filling systems and clean utilities. /liliProduce process documentation including Process Flow Diagrams, PIDs, and instrument lists. /liliDefine cleaning concepts (CIP/SIP), single-use strategies, and containment requirements for the filling area. /liliManage equipment procurement packages and coordinate with vendors throughout design, fabrication, and FAT. /liliLead process safety and risk assessments, including HAZOP, Sensor Risk Assessments (SRA), and FMEA. /liliCoordinate with automation and HVAC teams to align system boundaries and cleanroom classification requirements. /liliSupport commissioning and qualification by reviewing FAT/SAT specifications and witnessing site testing. /li /ulbrulliMaster's in Chemical, Process, Mechanical, Biotech, or Pharmaceutical Engineering. /liliYou have 5+ years of process engineering experience in the pharmaceutical or biotech industry, specifically with bulk filling or aseptic processing. /liliYou bring solid knowledge of strongGMP /strong, strongGAMP 5 /strong, strongEU Annex 1 /strong, and regulatory expectations for drug product handling. /liliYou possess experience writing strongURS /strong, strongFS /strong, strongERS /strong, and strongPIDs /strong while steering vendors through technical specifications. /liliYou have working knowledge of strongCIP/SIP /strong, strongsingle-use systems /strong, and clean utility design including strongWFI /strong and strongclean steam /strong. /liliYou're familiar with commissioning and qualification (CQ) deliverables such as strongSIA /strong, strongtraceability matrices /strong, and strongFAT/SAT /strong protocols. /liliYou are fluent in strongEnglish /strong. /li /ulbrpstrongNice to Haves /strong /pbrulliExperience with strongCOMOS /strong or other integrated engineering platforms. /liliFamiliarity with strongPED /strong, strongATEX /strong, strongEx zoning /strong, and high-potency product containment. /liliKnowledge of strongDutch /strong, strongFrench /strong, or strongGerman /strong. /li /ulbr/p #J-18808-Ljbffr