Jobs

Commissioning Engineer (C&Q)

Discipline
Engineering
Sector
Life Science
Location
Belgium
Vacancy ID
52884

Responsibilities

  • Write, review and approve commissioning & qualification protocols and reports, as well as execute protocols.
  • Work together with a small team of start-up personnel (incl. engineers, mechanical craft persons, E&I technicians, vendors etc.) and sometimes alone, to successfully execute start-up activities safely and to a high quality, based on the overall ICV schedule, for assigned systems.
  • Familiarize oneself with all elements of the process & utility design for assigned systems. This to be achieved through documentation & drawing review with the engineering company , Construction Management Team & team members.
  • Engage with the Construction Management Team & Construction team to review and approve the field installation (as per design) at Mechanical Completion. (P&ID Walk Downs)
  • Perform commissioning in a GMP biotech manufacturing facility
  • Provide technical assistance to less experienced technicians/engineers.
  • Review/approve commissioning documentation (e.g. vendor test documentation) for assigned systems
  • Resolve protocol discrepancies and deviations.
  • Generate, review and approve deviations
  • Report & follow up on deviations, solving technical problems
  • Participate in risk assessments
  • Perform change control assessment
  • Follow-up of changes via the applicable project change control procedure
  • Follow up on changes in own domain and communicate them to the relevant functions
  • Overseeing activities performed by third parties
  • Engage with technical support functions (e.g. process, automation etc.) to resolve issues quickly as they arise through commissioning execution.
  • Report on progress - frequency as per requested by Commissioning Lead.
  • Train operations personnel in system operations.

Requirements

  • We are looking for CQ profiles with at least 3 years of experience in C&Q
  • Knowledge of cGMP in a regulated environment is a must
  • The position requires daily interaction with other project team members (system owner, project engineer, ...), so we are looking for team players with good communication skills.
  • Degree of Masters Qualification in Science or Engineering is a plus
  • Knowledge of English is a must, knowledge of Dutch is a plus.
  • Experience with the Kneat application is a plus
  • Knowledge of (use) DeltaV / BMS is a plus
  • Valid VCA or equivalent is a must, valid VOL VCA or equivalent is a plus
  • Responsible for commissioning & qualification activities related to one or more of the following areas: FAT, SAT, DQ, IQ, OQ, PQ, and requalification activities for facilities, utilities, equipment.
  • This includes:
    • Adhering to all applicable laws and regulations and Sanofi policies and procedures.
    • Being honest and treating people with respect and courtesy.
    • Constantly striving to make the team a great place to work, respect for the quality of its people and products.
    • Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs.
    • Continuously looking for best practices and areas for improvement.

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