Description
Our client, a global pharmaceutical organisation based in the Netherlands, is looking for a Senior Process Engineer to support critical projects onsite within the Pharma Tech Support team.Role:
- Technological support, improvement / optimisation and innovation for manufacturing department
- Maintain stable / robust validated manufacturing processes that are in compliance
- Initiate and manage (and perform) trouble shooting (RCI's), P&A assessments, PV's, data analysis
- Perform regulatory / compliance checks and initiate relevant change controls
- Represent manufacturing department as user in investment (equipment, facility) projects
- Lead site to site transfers and support R&D transfers
Main Tasks:
- Project planning
- Lead (chair) general (improvement/optimization/innovation) cross functional (site) teams / projects as well as cross functional international (and site) teams / projects
- Set up MMI (Master Manufacturing Instruction), CPP (Critical Process Parameter) and CQA documents
- Lead, support and execute product and process RCI (OOS at release and in OGS) incl. CAPA plan
- Support regulatory variations and dossier updates
- Set up URS in investment programs in close collaboration with manufacturing/maintenance department
- Provide technical input for URS
- Act as owner of complex and cross-functional change controls (set-up, execution and closing)
- Draft process validation (PV) protocols
- Lead and execute PAA's (Process & Analytical Assessment)
- Participate and support R&D and lead / support Site to Site Transfer teams as technology expert
- Inform stakeholders about project progress
- Review (and write) PQ protocols for product related testing (existing and new equipment)
Documentation
- Set up documentation (project plans, protocols, reports) in English
- Review documentation (project plans, protocols, reports)
- Generate year plans (budget) and RFC's
- Write URS and PQ protocols/reports in English