Commissioning Engineer

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.