Job Title
Lead C&Q Engineer
Location
Limerick
Contract Type
Staff or Contract
Job Summary
We are seeking an experienced Lead Commissioning & Qualification (C&Q) Engineer to play a key leadership role on a large-scale, high-profile biopharma project.
This position will be responsible for overseeing C&Q activities across both upstream and downstream bioprocessing systems, working in close collaboration with the on-site C&Q Lead and cross-functional stakeholders.
The project focuses on the commissioning and qualification of bioreactor systems, ranging from small-scale development units to large commercial-scale operations, alongside supporting upstream and downstream process equipment.
This includes managing system readiness, coordinating execution across multiple vendors and workstreams, and ensuring seamless material flow through filtration and concentration systems delivering high-value product for final drug product manufacturing.
This is a high-impact, technically demanding role requiring strong leadership, coordination, and problem-solving capabilities.
It is ideally suited to senior C&Q professionals with a proven track record in delivering complex biopharma projects and managing integrated commissioning and qualification programmes.
Key Responsibilities
Lead and oversee the full lifecycle of Commissioning & Qualification (C&Q) activities across upstream and downstream process systems, in collaboration with the on-site C&Q Lead.
Act as the primary escalation point for technical issues, driving timely troubleshooting, resolution, and risk mitigation across all C&Q workstreams.
Conduct system walkdowns and readiness reviews to ensure systems meet pre-requisites for IQ commencement.
Ensure all C&Q activities are executed in compliance with GEP (pre-GMP) and GMP standards, maintaining inspection readiness at all stages.
Develop and manage the overall C&Q resource plan, including phased onboarding and offboarding aligned with project milestones and MC dates.
Track and report project progress, including publishing weekly Actual vs Planned updates to project leadership and key stakeholders.
Coordinate closely with Automation (including Emerson/DeltaV), vendors, Utilities, QA, and Validation teams to ensure integrated project delivery.
Oversee execution and review of C&Q documentation, including Commissioning Plans, SIAs, Risk Assessments (FMEA), IQ/OQ/PQ protocols, traceability matrices, and summary reports.
Support system handover to Operations, ensuring all punch-list items are resolved and systems meet operational and regulatory requirements.
Provide leadership, guidance, and mentorship to junior C&Q engineers, fostering technical development and consistent execution standards.
Support and oversee deviation management, change controls, CAPAs, and regulatory inspection readiness activities.
Qualifications
Degree in
Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline
10+ years' experience
in
Commissioning & Qualification / CQV / Validation
Strong working knowledge of
GMP requirements, FDA and EMA regulations
Strong
hands-on upstream and downstream bioprocess knowledge
Extensive experience working with
Bioreactors, Filtration and concentration systems
Excellent documentation, communication, and stakeholder engagement skills
Other Requirements
This is a site-based role.
Must be able to commit to a minimum 40-hour work week, with flexibility based on project needs.
Willingness to travel within
Ireland and internationally
, if required.
Eligible to work full-time in Ireland.
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