This candidate will be required to work closely with a cross-functional team and coordinate activities between Construction, Process, Technical Operations, IPT and QA.
Role functions:
Report to GES C&Q EMEA Lead /Project Manager on the given project.
Support all suite teams during a commissioning and qualification program.
Assist the C&Q Technical Lead in the planning and tracking of activities.
Actively support Last Planner System activities.
Liaise with the various stakeholders on the C&Q team and the overall project to ensure clear communication between all parties.
Participation in C&Q activities, as required.
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.
Role responsabilities:
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.
Attend daily communication meetings with suite teams, as required.
Assist in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents. Maintain a clean and safe working environment by enforcing procedures, policies, and regulations.
Education and Experience:
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.
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.
If you would like to hear a little bit more about it, please email me your CV to [email protected] or apply in the link below.
