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C&Q Lead

  • Location:

    Republic of Ireland

  • Contact:

    Noreen Daly

  • Job type:

    Contract

  • Contact phone:

    +353 21 485 7200

  • Industry:

    Biotechnology

  • Contact email:

    noreen_daly@oxfordcorp.com

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.