Headcount Solutions is currently recruiting for a Senior C&Q Engineer
on behalf of our multinational client**Apply on the website**;s
facility in Cork.
Reporting to C&Q Technical lead as part of a multi-discipline team
responsible for Commissioning & Qualification activities at the Drug
Product facility, this role has the following responsibilities:
* Assist the C&Q Technical Lead in the planning and tracking of
* Participation in GMP design reviews (DQ, CIA etc), 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
* Participate in generation, execution and approval of C&Q
documentation (FAT, SAT, IOC, DQ, IQ, OQ, IOQ) for the project based
on available approved client templates & design documentation.
* Review of CCRs and TOPs. May require travel to vendor shops and
frequent communication with vendors to ensure documentation
deliverables are per the VDRs.
* 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.
* Responsibility for direct supervision of vendor engineers and
contractors during C&Q activities.
* Confirm all vendor documentation executions are compliant with GxP
practices & the executed documentation is acceptable to support C&Q.
* Perform system P&ID walkdown with construction prior to handover.
Categorisation of punchlist items & tracking to completion
* Support review on all Isometrics, Weld logs, Weld Qualifications,
3rd Party Inspections, Material of Construction and Redlining
* Confirm the site installation is as per approved design
specification and meet system IQ requirements.
* Facilitate/expedite Mechanical Completion in conjunction with the
Construction team. (Liaise with construction contractors towards
successful completion of Construction Turn Over Documentation).
* Generate method statements, risk assessments & permit preparation
for responsible areas from M/C to handover to site operations.
* Assist in investigations of process equipment, utility systems, and
control system anomalies, as well as safety incidents.
* Coordinate with design and/or project teams to resolve any
identified technical issues.
* 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.
* Bachelor of Engineering or Science Degree in Engineering or
Technology related discipline.
* Minimum of 5 years**Apply on the website**; experience in
commissioning and/or validation of Drug Product Facilities/Utilities
systems within the 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.
* Working knowledge of process control systems and automation. DeltaV,
syringe & vial line experience is beneficial.
* Knowledge of C&Q documentation required for cGMP process equipment.
Please contact Mick on (phone number removed) for any queries or
submit cv in strict confidence to
We need : English (Good)