What are your responsibilities?
- Represent and manage the delivery of engineering and maintenance projects. The delivery of these projects will require GMP utility, facility and supporting system changes.
- Investigate and deploy innovative solutions to improve the efficiency of our current installations.
- ensure procedures are followed and new systems are implemented in compliance with FDA/EMA and other regulatory requirements.
- work directly with SMEs, vendors and customers to ensure regulatory (e.g. validation), business, functional and application specific requirements are met.
- Execute projects to 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 Site 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.
Who are we looking for?
- Bsc or Msc in Process/mechanical Engineering/Life sciences related field
- 5-10 years mechanical/projects background.
- Experienced in MS Project
- Experience with Cost/budget control
- Skilled in Change management
- Discipline and technical knowledge to work independently and take on responsibilities
What does QbD offer you?
- A young and dynamic company with a feel good culture, and a great openness and a no-nonsense approach
- Real investment in people through education and fun events
- A competence development model focused on your personal ambitions
- An attractive salary package
Interested? Apply now by sending us your CV and motivation.