The role:
PE Global is currently recruiting for a CQV Lead/PM on behalf of a leading biotech company based in Limerick. This is an initial 12 month contract role.
Summary:
Commissioning & Qualification Lead to provide technical support and leadership for new Process
Area CAPEX project.
Responsibilities:
* Prior to commissioning drive and track deliverables to completion – engineering and qualification documentation, FAT/SFAT executions, VTOPS reviews, Asset Builds etc.
* Support the handover of systems to operations by ensuring all issues are resolved and systems meet operational requirements.
* Oversee onsite setup and shakedown of new systems and equipment to ensure functionality and readiness for commissioning.
* Lead and oversee the execution of commissioning and qualification (CA, CTP, IQ, OQ, PQ) activities as per pre-approved protocols.
* Act as the primary point of escalation for troubleshooting and resolving issues during C&Q execution.
* Provide hands-on support to the C&Q team in identifying and addressing system issues.
* Collaborate with cross-functional teams, including engineering, validation, and operations, to ensure smooth execution of C&Q tasks.
* Ensure all commissioning and qualification activities comply with GEP and GMP standards.
* Conduct system walkdowns and support readiness reviews to verify systems are ready for C&Q.
* Communicate progress, challenges, and resolutions to stakeholders and project leadership.
* Coordinate with vendors and contractors to address equipment-specific issues and ensure compliance with project specifications.
Education and Experience:
* Minimum of 10 years of experience in commissioning and qualification in a regulated biopharma or pharmaceutical environment.
* Demonstrated expertise in troubleshooting and problem-solving during C&Q execution.
* Strong knowledge of biopharma equipment and systems (e.g., bioreactors, chromatography columns, filtration units, utilities).
* Proficiency in interpreting engineering drawings, P&IDs, and technical documentation.
* Familiarity with process control systems (e.g., DeltaV, PLCs) and automation systems.
* Excellent leadership and communication skills to manage teams and interface with stakeholders.
* Strong analytical and problem-solving abilities to resolve technical issues efficiently.
* Ability to work under pressure and manage multiple priorities in a fast-paced environment.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on or alternatively send an up to date CV to
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***