NOORD BRABANT, Netherlands
Mechanical Project Engineer
Our client is a professional organization within the pharmaceutical and biotech industry based in Noord-Brabant, The Netherlands. Their product portfolio encompasses the areas of oncology, kidney diseases, bone diseases, hematology and cardiovascular diseases.
As a Mechanical Project Engineer you will oversee the expansion and construction of the pharmaceutical facilities of this organization.
- Support Project Execution Plans (PEP) and ensure GMP standards.
- Monitor installation quality and record inspections.
- Monitor and ensure the highest levels of project safety
- Discover and understand end-user/process requirements; translate these into user requirements specifications.
- Compile and generate project documentation including URS/FS/HDS/FAT/SAT/TOPs.
- Manage design inputs to ensure robust, testable requirements are established and accurately reflect user and safety needs.
- Coordinate design decisions with the Amgen corporate engineering authority
- Manage day to day project activities including permitting/method statement review etc.
- Develop and document strong rational for testing strategy, acceptance criteria, and results.
- Generate, review, and/or approve protocols, reports ensuring robust documentation for regulatory adherence.
- Set up and manage communication channels – Weekly report out/Project Team Meetings.
- Follows a strict handover process to allow for future system maintenance.
- Bachelor's Degree in Engineering, preferably mechanical
- 10+ years of experience in Engineering roles
- Project Management experience, in construction and/or design
- GMP experience is a very strong plus
For more information please contact Carla Garcia at firstname.lastname@example.org or +31 (0) 20 658 98 01.