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.