Headcount Solutions Limited
Carlow, Carlow, Ireland
Job type: contract
Job industry: Engineering
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.
* 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).
* 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 below or forward details in confidence to