Job Details: Senior C&Q Engineer


JobsIreland
Jervis Street
Dublin 1
Senior C&Q Engineer
Senior C&Q Engineer

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
activities.

* 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
Traceability Matrix).

* 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
exercise.

* 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.

Requirements:

* 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)

Type: Permanent
Payment:
Category: Others

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