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Capex Lead CQV (H/F/X)

October 4th 2022

At Univercells, we are on a mission to make health equally accessible to all. We work every day to reinvent biomanufacturing processes and develop or integrate the next innovative technologies.

Mission Description

As part of our CAPEX Team and integrated in our C&Q department, you will work on several projects in close collaboration with your colleagues and different stakeholders.
 
As Capex Lead CQV, you have an excellent understanding of CQV execution methodologies for GMP pharmaceutical facilities, 
 
Some example of CAPEX projects are: 
 
  • Greenfield and/or Greyfield facility 
 
  • GMP clinical trials manufacturing & commercial launch 
 
  • Building, premises, manufacturing equipment (USP/DSP/filling) cleaning/sterilization/decontamination, black/clean utilities, IS/IT, QC/R&D labs, cGMP/EuGMP/WHO 
 
RESPONSIBILITIES:
 
  • Be the Commissioning / Qualification / Validation lead of Univercells for projects 
  • Lead planning and allocation of resources to meet CQV Project requirements both in the Office and on sites.
  • Manage team of C&Q Engineers on high profile client site throughout the project lifecycle
  • Organize and review daily activities of other CQV Engineers assigned to the project
  • Ensure site project execution is undertaken in compliance with company guideline, department procedures and safety standards
  • Review and follow-up technical documentation from the early design phase in order to ensure alignment with GMP and CQV requirements
  • Investigate and resolve technical issues with assistance from CSV engineers and/or suppliers
  • Insure connection with the various internal Univercells and external stakeholders (design offices, CQV service providers, suppliers, HSE, QA…)
  • Take ownership of the project stages already completed (Conceptual, Basic, Detailed Engineering, Call for Tenders/Procurement) 
  • Alignprojects CQV strategy in accordance with Corporate SOP
  • Ensure project management reporting relating to CQV (Schedule preparation and progress review, Final Handover reports…).
 

Candidate profile

  • Strong experience with Validation Master Plan, Commissioning Master Plan, project procedures and commissioning and qualification protocols (SAT/Commissioning, IQ and OQ)
  • Minimum Master's degree (or equivalent: industrial engineer, civil engineer, etc.)
  • Have strong experience with project team management
  • At least 10 years of professional experience in Commissioning project management 
  • Of which 4/5 in the field: CQV + biotech (viral vectors/vaccines) + systems listed above (§ context) 
  • Track record successful involvement in complex CAPEX project environments (>> 30M€, cGMP, biotech, fast-track) 
  • Successful project experiences according to ASTM E2500-13 (strategy implementation and execution) 
  • Experiences carried out in different contexts (clients, companies, size of projects) 
  • Constructive critical thinking, ability to innovate, “thinking outside the box” mindset
  • FR & EN (fluent)

Offer

Did you recognize yourself in this description and challenging role? We offer a long-term contract, a competitive salary package including many different benefits, and the possibility of evolution in an international, dynamic, and fast-growing company.

Contact Details

Is it appealing to you? Are you a powerful thinker combined with an efficient doer?

Apply now!