Engineering & Electronics
Senior C&Q Engineer
PE Global is currently recruiting for a Senior C&Q Engineer on behalf of our client based in Carlow. This is an initial 11 month contract role.
- Reporting to GES C&Q Lead EMEA as part of a multi-discipline team responsible for Commissioning & Qualification (C&Q) activities on a number of equipment packages in a multi-product facility.
- C&Q Lead will be part of a Cross Functional Suite Team with responsibilities for the day to day C&Q activities of the Suite
- Lead the Suites C&Q activities, managing the Suite C&Q resources
- Planning and tracking of Suites C&Q activities.
- Actively support Last Planner System activities.
- Review and Input into deliverables such as technical requirement specifications and vendor turnover documentation.
- Participate in C&Q deliverables (System Impact Assessment, Critical Component Impact Assessments, System Boundary Drawings, Requirement Traceability Matrix).
- Manage generation and execution of C&Q documentation (FAT, SAT, IOC, DQ, IQ, OQ, IOQ) for the project based on available approved client templates & design documentation.
- Monitor and report on approval of C&Q documentation.
- Monitor and report review of CCRs and TOPs.
- Participate in C&Q change controls (FDCNs and PCNs) and drive their closure in a timely manner. Ensure non-conformances & deviations are minimised and closed out in a timely fashion.
- Support system P&ID walkdown with construction prior to handover. Categorisation of punchlist items & tracking to completion.
- Support review on all Isometrics, Weld logs, Weld Qualifications, 3rd Party Inspections, Material of Construction and Redlining exercise.
- Facilitate/expedite Mechanical Completion in conjunction with the Construction team.
- Pre-start up safety checks, LOTO & ensuring timely loop checking and calibrations.
- Coordinate and supervise third party vendors during SAT execution. Review and approve SAT protocols.
Education and Experience:
- Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
- Minimum of 5 years’ experience in commissioning and/or validation of USP/DSP/Facilities/Utilities systems within Pharmaceutical industry.
- Technical knowledge of Sterile Filling equipment, biotechnology processes and a working knowledge of FDA and EU regulations is preferred.
- Knowledge of C&Q documentation required for cGMP process equipment.
- Working knowledge of word processing, spreadsheets, database management software, CAD software, and PCs.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to firstname.lastname@example.org