The PHENX team creates pragmatic CQV/CSV solutions for the Life Science Industry. With a constant evolving team composed by employees and freelances and offices in Ghent, PhénX is now looking for Senior Project Manager/Coordinator CQV in Biotech

• Are you a guru in Life Science/Biotech Commissioning, Qualification, Validation domain?
• Talented in leading projects and teams?
• Is the interpretation of the current GMP guidelines and regulations a game for you?
• Are you looking forward to making part of a human-sized company?

We love meeting smart and forward-thinking talents, so don’t hold back!

• You will manage/coordinate CQV projects within the Life Science/Biotech Industry from start to finish (incl. change management).
• You understand your customer needs better than your own and design a CQV project strategy that fits your customer and compliance needs.
• You partner with customer the project team (Management, discipline leads, system owners, QA, Engineering & Technical Services,…) and with the other project partners (Engineering Office, Equipment suppliers,…).
• You turn problems into solutions and develop and maintain a clear project execution strategy.
• You manage/coordinate the PHéNX project team and prioritization of the project CQV activities.
• You and your team create, execute and document all relevant CQV project deliverables (VMP, URS, RA, GMP, Design reviews, Commissioning (FAT/SAT) and qualification protocols, test sheets and reports. (where applicable based on PHéNX company standards).
• You follow up the CQV activities of your team, technicity challenges, correct interpretation of GMP guidelines, technical changes and corrective actions
• You drive, safeguard and control the project CQV project schedule
• You prepare the necessary internal performance and progress reports (progress vs planning vs budget)
• You guarantee the project quality and visualize key Quality indicators
• You master the project budgets

The projects are mainly situated in the Life science/Biotech Industry:

• Vaccines: m-RNA, viral vector, mAbs…
• Cell/gene/protein therapies
• DS/DP/Formulation/Filling

The projects consist of the following packages/discipline:

• Facilities: HVAC, cleanroom finishes, Interlock, EMS,
• Clean Utilities production, storage and distribution (WFI, PW, PS, clean gasses)
• Prim. & Sec. Process equipment: bioreactors, filter systems, autoclaves , decontamination systems, ….
• Filling systems
• Automation and process control

We are looking for different people in different regions:

• Wallonia
• East/West Flanders and Antwerp
• Limburg, Kempen and adjacent Netherlands

• Project Managers in heart and soul
  • Experienced people manager/motivator
  • Proactive problem solver
  • Project planning wizard
  • Change management guru
• Driven by a customer and human-focused approach
  • You accompany your customer and your teams over the project challenges
  • You strive for continuous lean excellence in projects and systems
• Biotech/GMP specialist
  • You have a good Comprehension and understanding of technical installation, equipment, and buildings for the Life Science/Biotech Industry
  • You have a thorough technical background in GMP, Biotech systems, equipment, and processes
  • You can build CQV strategies and adapt them to customer needs
  • You are eager to follow the latest trends in GMP, CQV, Biotech
• You are analytical, structured, conscientious, and precise

We are a close team of multidisciplinary solutions finders. We are result and human-focused

• Our broad and thorough knowledge
• Our creativity
• Our adaptability
• Our accessible

• Team cohesion
• Transparency
• Operational excellence

We’re looking for motivated and passionate individuals who love to build things and solve problems.

If this is you, please address your application,

CV and a short motivation text, to us:

hr@phenx.be with Reference « Senior Project Manager/Coordinator CQV in Biotech »

or call +32 479 / 98 46 69.