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Senior CQV Engineer
PM Group —Tipperary, County Tipperary
- Manufacturing
8d

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Senior CQV Engineer

PM Group -
Tipperary, County Tipperary

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Job details

8 days ago

Qualifications

Mechanical Engineering
Construction
Manufacturing

Full job description

The Outsourced Technical Services (OTS) Department at PM Group partners with global industry leaders across a range of sectors to provide skilled professionals for both current and long-term business needs. Working with PM Group and our clients offers the opportunity to contribute to some of the most exciting and technically challenging projects in Ireland and internationally, while benefiting from excellent career development opportunities, competitive benefits, and long-term assignments.

We are currently seeking a Senior C&Q Engineer to join our dynamic and innovative OTS team. The Senior C&Q Engineer will lead commissioning, qualification, and startup activities for API manufacturing process trains within a major brownfield Pharmaceutical Project. The role will be responsible for the safe and compliant delivery of process systems from construction through qualification and handover while working within a live GMP manufacturing environment.

Lead Commissioning & Qualification activities for API process trains.
Execute and oversee FAT, SAT, Commissioning, IQ, OQ, and startup activities.
Perform system walkdowns, Mechanical Completion verification, and turnover package reviews.
Develop, review, and execute commissioning and qualification documentation within Kneat.
Coordinate punch list generation, tracking, and closure through to handover.
Support PSSR/PSSER activities, risk assessments, change controls, deviations, and CAPAs.
Review P&IDs, equipment specifications, vendor packages, and process design documentation.
Coordinate vendors and contractors during commissioning, qualification, and startup phases.
Interface with Operations, Quality, Engineering, Construction, and Automation teams to ensure project milestones are achieved.
Ensure all activities are executed in compliance with GMP, GDP, and site quality requirements.
Experience commissioning and qualifying API process equipment including:

Glass-Lined and Stainless-Steel Reactors
Filter Dryers
Nutsche Filters
Centrifuges
Crystallizers
Process Vessels and Holding Tanks
Heat Exchangers
Solvent Recovery Systems
Process Transfer Systems
CIP Systems
Process Pipework and Skid Packages

Support qualification of associated utilities including Plant Steam, Nitrogen, Chilled Water, Cooling Water, HVAC, Compressed Air, Vacuum Systems
Review P&IDs, process flow diagrams, equipment datasheets, vendor packages, and turnover documentation.
Coordinate vendors and contractors during commissioning, startup, and qualification phases.
Interface with Operations, Quality, Automation, Engineering, and Construction teams to deliver systems safely and compliantly.

Degree in Chemical, Process, Mechanical Engineering, or related discipline.
8+ years' experience in Pharmaceutical/API manufacturing projects.
Proven experience delivering commissioning and qualification activities on large capital or brownfield API projects.
Strong knowledge of GMP manufacturing processes and regulatory requirements.
Experience using Kneat for digital CQV execution.
Experience with DeltaV systems, alarms, interlocks, and process control strategies.
Strong understanding of Mechanical Completion, System Turnover, Startup, and Operational Readiness processes.

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Senior CQV Engineer

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