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C&Q Engineer

Reference ID : 075MQ
Category :
  • Pharma / Biotech
Date Posted : Jun 19, 2020
Job Location
:
  • Leinster
- Carlow
Ireland
Experience : Minimum 8 years
Salary : Negotiable - DOE
Employment Type
:
Contract
Consultant
:
Michael McQuade
Contact Number : 0860435195
Seeking a C&Q Manager for a leading multinational pharma facility.

Principal Responsibilities

C&Q Manager

Reporting to Global Engineering Solutions C&Q Lead EMEA as part of a multi-discipline team responsible for Commissioning & Qualification (C&Q) activities on a multi-product facility, this person will project manage the day to day C&Q activities of the C&Q team.

Responsibilities

  • Implement company C&Q strategies as set out by the C&Q Lead EMEA.
  • 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.
  • 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).
  • Ensure that system delivery progresses in accordance with the approved project schedule.
  • Notify C&Q Technical Lead, in a timely manner, of all relevant issues which may impact on system progress.
  • 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.
  • 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.
  • 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.
  • Facilitate/expedite Mechanical Completion in conjunction with the Construction team. (Liaise with construction contractors towards successful completion of Construction Turn Over Documentation).

 


Qualifications & Requirements

Requirements:

  • 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.

For further information, please contact Mick on 086-04351975 or forward details in confidence to jobs@headcount.ie




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