The Commissioning Engineer will be responsible for the commissioning of designated systems (both utility and process). The role will involve guiding a small team, as well as part of the larger ICV organization and engaging with various groups including design, construction, manufacturing, quality & engineering for the project.
The role of the commissioning engineer will be one of direct responsibility, on behalf of Sanofi, for the successful commissioning of defined systems. (incl. loop checks and passivation, where applicable).
Reporting to the Commissioning Lead or manager, the role of the commissioning engineer will be as follows:
- 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 (JE), Construction Management Team & Sanofi team members.
- Engage with the Construction Management Team & Sanofi 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.
- 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.
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