Commissioning Engineer

7 days ago

Dublin Pike, Ireland PE Global Full time

Overview PE Global is currently recruiting for a Commissioning Engineer for a leading multi-national Pharma client based in South Dublin.
This is a contract position.
Role Overview We are seeking a contract CQV Engineer with proven experience in commissioning and qualification of equipment and utilities in a drug substance (DS) manufacturing environment. The successful contractor will play a critical role in delivering a fast-paced CQV program in line with GMP, project timelines, and regulatory expectations.
You’ll be expected to work independently or as part of a cross-functional CQV team to author and execute qualification protocols, manage deviations, and support system handover for GMP operations.
Key Responsibilities Deliver end-to-end CQV lifecycle documentation: URS, DQs, FAT/SAT, IQ, OQ, and support for PQ where applicable.
Perform equipment and system commissioning, including verification of installation, utilities integration, control functionality, and safety systems.
Lead CQV efforts on systems including (but not limited to): Bioreactors and single-use technologies; Chromatography Columns; Clean-in-place (CIP) and steam-in-place (SIP) systems; WFI, clean steam, and process gases; Process tanks, skids, and associated piping.
Conduct impact assessments, risk assessments (e.g. ASTM E2500), and define appropriate qualification strategies.
Liaise with vendors, automation, engineering, and quality functions to coordinate execution and resolve issues.
Support and lead the resolution of deviations, non-conformances, and change controls related to CQV scope.
Maintain up-to-date and compliant documentation in line with GMP and data integrity requirements.
Provide progress updates and contribute to system readiness reviews and handover milestones.
Experience and Qualifications Bachelor’s degree in Engineering, Life Sciences, or related technical field.
Minimum 5 years’ CQV experience in a GMP-regulated drug substance or biologics manufacturing environment.
Hands-on experience with commissioning and qualification of large-scale bioprocess equipment; utility systems (WFI, HVAC, compressed gases, clean steam); automation-integrated equipment (DeltaV).
Deep understanding of CQV best practices, ISPE Baseline Guides, GAMP 5, and ASTM E2500.
Experience working on capital projects, preferably from construction to handover.
Ability to work independently on protocol development, execution, and resolution management.
Application and Visa Note Interested candidates should submit an updated CV. Please click the link below to apply, or alternatively send an up-to-date CV to niamh.mcdonald@peglobal.net.
Note: Our client cannot assist with visa sponsorship and candidates must have the correct visa to live and work in Ireland.
Location & Compensation Dublin, County Dublin, Ireland
Salary: €50,000.00-€70,000.00

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