Careers

• Are you a structured, conscientious, and precise fast learner?
• Are you a real team player who can also work independently?
• Do you have a CAN-DO mentality who can think proactively?
• Do you have the knowledge and practical experience of the latest developments in the CQV (commissioning & qualification) field and cGMP.

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

• You will be part of a young team of CSV engineers under the guidance of a project manager.
• You will prepare project CQV deliverables:
  • User Requirement Specifications
  • Risk and Impact Analysis/Assessment (Process, Business, EHS, Regulatory)
  • Validation Master Plan (VMP)
  • Design Review/Qualification
  • Test Matrices
  • FAT, SAT, Commissioning, IQ, OQ, PQ protocols and reports
• You will broaden your knowledge of current industry standards, regulatory requirements and Authority expectations regarding CQV.
• You will support in the project schedule for CQV activities.
• You will organize, execute and document CQV testing.
• You will support during system/installation start-up in the function of CQV test activities.
• You will set up and follow up of the Project documentation System and Management.
• You will work in close collaboration with Project, Engineering and Construction Management.
• You will be in charge of the registration of quality indicators for the CQV Engineer’s discipline.

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

The CQV Engineer has proven record of

• a (Professional) Bachelor or a Master’s degree (or equivalent by experience), ideally in bio, industrial, pharma, chemical or relevant other expertise.
• a first experience in Life Sciences industries.

The CQV Engineer has

• excellent communication skills in English, French and/or Dutch (written and spoken).
• knowledge of current Industry Standards, Regulatory requirements and Authority expectations (Eudralex, FDA, PICS, ICH, ISO, ASTME2500,….) is an advantage.
• a comprehension and understanding of technical installation, PID, equipment and buildings for the Life Science Industry.
• a field experience with:
  • system start-up and CQV
  • project scheduling
  • change management
  • project document management

Besides an exciting flexible environment, a unique chance to participate in challenging and innovative projects and interaction with inspiring colleagues, who have a professional attitude and attach considerable importance to teamwork.

We stand for:

• a challenging position
• a full time contract
• location: Flexible depending to clients’ locations
• a challenging job in a dynamic and knowledge-sharing network company
• the freedom to develop yourself in line with your ambition
• a great autonomy in your role, an excellent working atmosphere within a great team of Experts in their domain
• a competitive salary
• other benefits including a company car, fuel card, lunch vouchers, eco vouchers, pension plan, phone subscription

• Are you a structured, conscientious, and precise fast learner?
• Are you a real team player who can also work independently?
• Do you have a CAN-DO mentality who can think proactively?
• Do you have the knowledge and practical experience of the latest developments in the CQV (commissioning & qualification) field and cGMP.

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

• You will broaden your knowledge of current industry standards, regulatory requirements, and Authority expectations regarding CQV.
• You will develop a project-specific CQV approach and methodology.
• You will prepare project CQV deliverables:
  • User Requirement Specifications
  • Risk and Impact Analysis/Assessment (Process, Business, EHS, Regulatory)
  • Validation Master Plan (VMP)
  • Design Review/Qualification
  • Test Matrices
  • FAT, SAT, Commissioning, IQ, OQ, PQ protocols and reports
• You will support in the project schedule for CQV activities.
• You will organize, execute and document CQV testing.
• You will support during system/installation start-up in the function of CQV test activities.
• You will set up and follow up of the Project documentation System and Management.
• You will work in close collaboration with Project, Engineering, and Construction Management.
• You will be in charge of the registration of quality indicators for the CQV Engineer’s discipline.

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

The CQV Engineer has proven record of

• a (Professional) Bachelor or a Master’s degree (or equivalent by experience), ideally in bio, industrial, pharma, chemical or relevant other expertise.
• a significant experience in Life Sciences industries.

The CQV Engineer has

• excellent communication skills in English, French and/or Dutch (written and spoken).
• an enhanced knowledge of current Industry Standards, Regulatory requirements and Authority expectations ( Eudralex , FDA, PICS, ICH, ISO, ASTME2500, ….).
• a good comprehension and understanding of technical installation, PID, equipment and buildings for the Life Science Industry.
• knowledge of the latest developments in the CQV field and relevant legislation and industry standards (cGMP).
• a field experience with:
  • system start-up and CQV
  • project scheduling
  • change management
  • project document management

Besides an exciting flexible environment, a unique chance to participate in challenging and innovative projects and interaction with inspiring colleagues, who have a professional attitude and attach considerable importance to teamwork.

We stand for:

• a challenging position
• a full time contract
• location: Flexible depending to clients’ locations
• a challenging job in a dynamic and knowledge-sharing network company
• the freedom to develop yourself in line with your ambition
• a great autonomy in your role, an excellent working atmosphere within a great team of Experts in their domain
• a competitive salary
• other benefits including a company car, fuel card, lunch vouchers, eco vouchers, pension plan, phone subscription

• Are you a structured, conscientious, and precise fast learner?
• Are you a real team player who can also work independently?
• Do you have a CAN-DO mentality who can think proactively?
• Do you have the knowledge and practical experience of the latest developments in the CSV (Computer system validation) and cGMP.

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

• You will be part of a young team of CSV engineers under the guidance of a project manager.
• You will prepare project CSV deliverables:
  • User Requirement Specifications
  • Risk and Impact Analysis/Assessment (Process, Business, EHS, Regulatory)
  • Validation Master Plan (VMP)
  • Design Review/Qualification
  • Test Matrices
  • FAT, SAT, Commissioning, IQ, OQ, PQ protocols and reports
• You will broaden your knowledge of current industry standards, regulatory requirements, and Authority expectations regarding CSV.
• You will support the project schedule for CSV activities.
• You will organize, execute and document CSV testing.
• You will support during system/installation start-up in the function of CSV test activities.
• You will set up and follow up of Project documentation System and Management.
• You will work in close collaboration with Project, Engineering, and CQV Management.

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

The CSV Engineer has proven record of

• a (Professional) Bachelor or a Master’s degree (or equivalent by experience), ideally in automation-regulation, IT or relevant other expertise.
• a first experience in Life Sciences industries and industrial automation processes.

The CSV Engineer has

• excellent communication skills in English, French and/or Dutch (written and spoken).
• knowledge of current Industry Standards, Regulatory requirements and Authority expectations (Eudralex, FDA, PICS, ICH, ISO, ASTME2500, ….) is an advantage.
• a field experience with the following is an advantage:
• Scada, supervision and computerized system
• IT regulation
• Computerized System Validation

Besides an exciting flexible environment, a unique chance to participate in challenging and innovative projects and interaction with inspiring colleagues, who have a professional attitude and attach considerable importance to teamwork.

We stand for:

• a challenging position
• a full time contract
• location: Flexible depending to clients’ locations
• a challenging job in a dynamic and knowledge-sharing network company
• the freedom to develop yourself in line with your ambition
• a great autonomy in your role, an excellent working atmosphere within a great team of Experts in their domain
• a competitive salary
• other benefits including a company car, fuel card, lunch vouchers, eco vouchers, pension plan, phone subscription

• Are you a structured, conscientious, and precise fast learner?
• Are you a real team player who can also work independently?
• Do you have a CAN-DO mentality who can think proactively?
• Do you have the knowledge and practical experience of the latest developments in the CSV (Computer system validation) and cGMP.

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

• You will broaden your knowledge of current industry standards, regulatory requirements, and Authority expectations regarding CSV.
• You will develop a project-specific CSV approach and methodology.
• You will prepare project CSV deliverables:
  • User Requirement Specifications
  • Risk and Impact Analysis/Assessment (Process, Business, EHS, Regulatory)
  • Validation Master Plan (VMP)
  • Design Review/Qualification
  • Test Matrices
  • FAT, SAT, Commissioning, IQ, OQ, PQ protocols and reports
• You will support the project schedule for CSV activities.
• You will organize, execute and document CSV testing.
• You will support during system/installation start-up in the function of CSV test activities.
• You will set up and follow up of Project documentation System and Management.
• You will work in close collaboration with Project, Engineering, and CQV Management.

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

The CSV Engineer has proven record of

• a (Professional) Bachelor or a Master’s degree (or equivalent by experience), ideally in automation-regulation, IT or relevant other expertise.
• a significant experience in Life Sciences industries and industrial automation processes.

The CSV Engineer has

• excellent communication skills in English, French and/or Dutch (written and spoken).
• an enhanced knowledge of current Industry Standards, Regulatory requirements and Authority expectations ( Eudralex , FDA, PICS, ICH, ISO, ASTME2500, ….).
• a good comprehension and understanding of technical installation, PID, equipment and buildings for the Life Science Industry.
• knowledge of the latest developments in the C&O field and relevant legislation and industry standards (cGMP).
• a field experience with:
  • Scada, supervision and computerized system
  • IT regulation
  • Computerized System Validation

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!

• 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