C&Q Lead , ,

Job Description

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
This candidate will be required to work closely with a cross-functional team and coordinate activities between Construction, Process, Technical Operations, IPT and QA

Responsibilities

Report to GES C&Q EMEA Lead on the given suite
Liase with Suite Lead on all C&Q Activities
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.
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 punch list 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. (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.
Implement the Clients GES C&Q strategies as set out by the GES C&Q Lead EMEA.
Ensure that system delivery progresses in accordance with the approved project schedule.
Notify Suite Lead and and GES C&Q Lead EMEA, in a timely manner, of all relevant issues which may impact on system progress.
Ability to work in design and construction project environment within Ireland.
Ensure that all works carried out in C&Q scope or responsibility by construction, commissioning and contract team members are performed in accordance with site safe working practices.
Ensure the cohesive operation of cross-functional team and coordinate work for effective and efficient completion.

Requirements

Experience of leading C&Q activities on multiply equipment packages
Sterile Filling C&Q Equipment Experience
Knowledge of C&Q documentation required for cGMP process equipment.
Fluent in English.
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.
Knowledgeable with latest industry standards and guidelines on C&Q, including ISPE/ASTM
Strong interpersonal and communication skills (verbal/written)

Responsibilities

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.