PROJECT COORDINATOR

Braine l'AlleudIPharmaceutical Sector

Job description

For one of our pharmaceutical clients in Brussels we are looking for a NPI PROJECT COORDINATOR.

As NPI Project Coordinator, you will join a dynamic team under the responsibility of the NPI Project Leader. Each NPI Project Coordinator is responsible within the team of one strategic DP.

You will be responsible to ensure completion of the anti-Tau project (mAbs) to deliver the drug product (DP) units on time to supply the phase 3 clinical trials and prepare its commercial launch.

As NPI Project Coordinator, your responsibilities are:

  • Design and implement an efficient DP manufacturing process
  • Design, buy and qualify new single use systems (SUS)
  • Define with local teams (prod, QA, Q&V, ENG, DEV, RA) the best qualification strategy (equipment and materials)
  • Coordinate the manufacturing activities of technical batches
  • Coordinate the manufacture activities of engineering / stability batches
  • Define with local teams (prod, QA, Q&V, ENG, DEV, RA) the best process validation strategy
  • Coordinate the manufacture of process validation batches
  • Write and/or review and/or approve project / production / qualification documentation
  • Coordinate the sampling and transfer of samples to each QC labs
  • Coordinate the review and release of development batches
  • Give support to operational activities (management of deviation, change control and training)
Profile

As Project Coordinator you match the following qualifications:

  • Master’s degree as Bio-Engineer, Industrial Pharmacist or proven experience
  • More than 10 years' experience in the (bio)pharmaceutical industry
  • Strong knowledge of aseptic manufacturing practices
  • Strong knowledge of bulk, aseptic filling and visual inspection processes
  • Strong knowledge of design and qualification of single use systems (e.g. assembly, bag, tank)
  • Deep knowledge of filter validation package (bacterial challenge, integrity, compatibility, leachable & extractable testing, etc)
  • Demonstrated experience in aseptic manufacturing, drug product process design, process performance qualification (PPQ), equipment design (URS, DV) and qualification (IQ, OQ, PQ)
  • Excellent communication skills to work within cross-functional teams
  • Fluent in French and English (reading, writing and speaking)
  • Respectful behavior, resourceful, team player, flexible, empathic and good problem-solving mind (including conflicts management skills), open minded & stress resistant
  • Certification in project management (e.g. PMI, Prince2) and operational excellence (Yellow Belt, Green Belt) are nice to have
Organisation and department description

Select Projects is part of the Select group, a collection of HR companies that put people first because Quality is Performance by Genuine People. Select Projects provides technical support to clients on a project basis. Our 220 employees in Belgium and the Netherlands support companies with their projects in various domains: Life Sciences, (petro) chemical, Construction and Rail. From our offices in Antwerp and Rotterdam we optimally support our experienced specialists so that they can deliver high quality to our customers at all times.

Offer

You get an attractive salary package with interesting fringe benefits. A company car, meal vouchers, group insurance and mobile phone subscription are possible. We ensure that you end up in a pleasant working environment with nice colleagues and opportunities to develop and further develop. Together with you, we map out a training course tailored to your future plans and needs.

Any questions?
Marlies Collart Consultant Life Sciences Select Projects +32 3 203 50 80
PROJECT COORDINATOR Vacancy information
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Engineering Projects
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