Our client is looking for a GMP Project Engineer who can represent and manage the delivery of engineering and maintenance projects. The delivery of these projects will require GMP utility, facility and supporting system changes.
The successful candidate must have the discipline and technical knowledge to work independently and take on responsibilities as demanded by these projects. They must investigate and deploy innovative solutions to improve the efficiency of our current installations. They must ensure procedures are followed and new systems are implemented in compliance with FDA/EMA and other regulatory requirements.
They will work directly with the company's SMEs, vendors and customers to ensure regulatory (e.g. validation), business, functional and application specific requirements are met.
Responsibilities- Execute projects to the company's Project Execution Plan (PEP) and meet all GMP requirements;
- Ensure the highest levels of project safety;
- Identify project critical paths and prioritize accordingly;
- Discover and understand end-user/process requirements; translate these into user requirements specifications;
- Compile all 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;
- 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;
- Monitor installation quality and record inspections – Comply to the company and Dutch standards;
- Set up and manage communication channels – Weekly report out/Project Team Meetings;
- Follows a strict handover process to allow for future system maintenance.
Our client is a professional Pharmaceutical organisation, based in Noord-Brabant Netherlands. This client is an international pharmaceutical organization, specialized in the packaging and distribution of medicines with a powerful sense of shared purpose toward their mission: to serve patients.