Lead C&Q Engineer

CAI; Limerick; On-site; EUR 80,000 - 100,000; Full time

Job summary

CAI is looking for a Lead C&Q Engineer in Limerick to oversee C&Q activities on a major biopharma project. This role requires an experienced professional with over 10 years in CQV/Validation, possessing strong knowledge of GMP and regulatory requirements. The key responsibilities include leading C&Q activities, ensuring compliance, and mentoring junior engineers. Candidates should hold an engineering degree and be eligible to work in Ireland, with a commitment of 40+ hours per week.

Qualifications

• 10+ years’ experience in Commissioning & Qualification / CQV / Validation.
• Strong working knowledge of GMP requirements and FDA/EMA regulations.
• Extensive experience working with bioreactors.

Responsibilities

• Lead and oversee C&Q activities across upstream and downstream process systems.
• Act as the primary escalation point for technical issues.
• Conduct system walkdowns and readiness reviews.

Skills

GMP requirements and FDA/EMA regulations

Hands-on upstream and downstream bioprocess knowledge

Excellent documentation, communication, and stakeholder engagement skills

Education

Degree in Engineering, Biotechnology, or Pharmaceutical Sciences

Tools

Bioreactors

Filtration and concentration systems

Job description

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.