Engineering & Electronics
Senior C&Q Project Manager
PE Global is currently recruiting for a Senior C&Q Project Manager on behalf of our client based in Carlow. This is an initial 12 month contract role.
- Project Manage the day to day C&Q activities of the C&Q team.
- Liaise with Project Controls function.
- 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, and 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 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.
- Ability to work in design and construction project environment within Ireland.
- Coordinate with design and/or project teams to resolve any identified technical issues.
- Organise/attend all coordination meetings necessary to progress the job. Possess good communication skills.
- Facilitate/expedite Mechanical Completion in conjunction with the Construction team. (Liaise with construction contractors towards successful completion of Construction Turn Over Documentation).
- 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.
- Maintain a clean and safe working environment by enforcing procedures, policies, and regulations.
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 black utilities and clean utilities systems and equipment, biotechnology processes and a working knowledge of FDA and EU regulations is preferred.
- Experience in C&Q as a C&Q Lead/Project Manager on a major capital project.
- Working knowledge of process control systems and automation. DeltaV, syringe & vial line experience beneficial.
- Knowledge of C&Q documentation required for cGMP process equipment.
- Fluent in English, written and verbal.
- Ability to understand project plans and schedules.
- Working knowledge of word processing, spreadsheets, database management software, CAD software, and PCs.
- Knowledge of regulations and standards affecting devices, biologics and pharma products.
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