Project Engineer

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.