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Pm parenterals

Saint-Gilles
EPM Scientific
Publiée le 30 août
Description de l'offre

Join a leading global life sciences organisation at the forefront of pharmaceutical product development. This is your chance to take ownership of critical parenteral equipment projects in a multi‐product pilot plant environment, where sterile manufacturing excellence meets cutting‐edge engineering. As a C&Q Project Manager you will... Lead planning, execution, and documentation of equipment qualification/validation for parenteral manufacturing systems (e.G. processors, fill‐finish, CIP/SIP, lyophilizers, autoclaves, dry heat ovens, nano‐milling). Prepare, execute, and review aseptic process simulations, including media fills and re‐validations. Draft technical specifications, URS, risk assessments, and validation protocols/reports. Manage FAT/SAT, commissioning, and construction supervision for new or modified equipment. Facilitate GMP risk analyses and lead CAPA/change control management. Act as equipment owner in multidisciplinary teams, liaising with QA and other stakeholders. Drive improvement initiatives and gap assessments within the pilot plant environment. As a C&Q Project Manager you have... Master's degree in a technical field (or equivalent experience). 5+ years' pharmaceutical engineering experience with proven qualification/validation expertise. Strong GMP, GDP, and data integrity knowledge. Direct experience with parenteral manufacturing equipment & aseptic processing. Expertise in risk analysis tools (FMEA) and regulatory compliance. Project leadership skills using FPX or equivalent methodologies. Professional fluency in Dutch and strong English communication skills. Proficiency in MS Office (Excel, Word, Teams, MS Project). Willingness to travel ~20% for FAT activities.

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