CSV Project Manager

PHENX; Netherlands; Remote; EUR 90,000 - 130,000; Full time

Job summary

PHéNX is seeking a Senior Project Manager/Coordinator CQV in Biotech to lead CQV projects in Life Science with a hands-on, pragmatic approach. You’ll steer teams, balance GMP/GAMP requirements with project realities, and deliver compliant, on-time results.

You will manage customer relationships, design CQV strategies, coordinate with engineering, QA, and suppliers, and mentor a tight, capable project team across regions in Wallonia, East/West Flanders, Antwerp, Limburg and adjacent Netherlands.

Qualifications

• Experience leading CQV projects in Life Science/Biotech.
• Strong GMP knowledge and ability to design CQV strategies.
• Customer-focused with change management skills.

Responsibilities

• Lead CQV projects from start to finish in Life Science/Biotech.
• Coordinate with management, QA, engineering and suppliers.
• Develop project execution plans and track progress against budget.
• Ensure data integrity, qualification protocols and reports are delivered on time.

Skills

People management

Project planning

GMP/GAMP knowledge

CQV

Biotech industry

Problem solving

Tools

SCADA/DCS

PLC

LIMS

EDMS

WMS/EMS/AMS

Job description

The PHéNX 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.

We’re not just looking for anyone

You’re not just managing timelines. You’re steering teams, balancing GMP and GAMP requirements with reality and keeping biotech projects on track without losing your mind (or sense of humour).

We’re looking for a CSV Project Manager/Coordinator who’s done the work, understands the pressure and still loves the game.

This role is for you if:
You know your way around commissioning, qualification & validation.
You speak the language of cleanrooms, utilities and bioreactors and even better of SCADA/DCS, process control, PLC, PCS, software packages, data integrity, WMS, EMS, AMS, LIMS, EDMS…
You bring structure, clarity and a human touch to complex projects.

We’re not a big machine. We’re a tight team of sharp minds and real people. Focused, pragmatic and allergic to corporate theater. We love meeting smart and forward-thinking talents, so don’t hold back!

The challenges we take on as a team

• 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

Domains

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

• 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

Who are we looking for

• 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 look forward to having you on board soon!

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

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