Lead Commissioning & Qualification Engineer

Job Description: Lead C&Q Engineer

CAI Overview
Are You Ready?

CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years.

Our approach is simple because our Purpose informs everything we do:
• We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.

At CAI, we are committed to living our Foundational Principles, both professionally and personally:
• We act with integrity
• We serve each other
• We serve society
• We work for our future

At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done.

Job Title: LeadC&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.