PM parenterals
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.
FAQs
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