Senior C&Q/Shakedown Engineer

Job Description: Senior C&Q/Shakedown 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: Senior C&Q Engineer

Location: Limerick

Contract Type: Staff or Contract

---

Job Summary

We are seeking an experienced C&Q / Shakedown Engineer to support commissioning activities on a large-scale, high-profile biopharma project. This role will focus on the hands-on execution, optimisation, and stabilisation of upstream and downstream bioprocessing systems, working closely with C&Q Leads, Automation, and cross-functional project teams.

The project centres on the commissioning and qualification of bioreactor systems, ranging from small-scale development units to large commercial-scale operations, alongside supporting process equipment including CIP/SIP, chromatography, filtration, and buffer systems. The role will involve system setup, shakedown, and performance tuning to ensure equipment operates reliably and meets Good Engineering Practice (GEP) standards prior to qualification.

This is a technically demanding, site-based role requiring strong troubleshooting, coordination, and problem-solving capabilities. It is ideally suited to senior-level engineers with proven experience in commissioning complex biopharma systems and driving systems from mechanical completion through to stable operation and handover.

---

Key Responsibilities

· Act as the Commissioning SME for assigned equipment packages (e.g. Bioreactors, CIP/SIP, Chromatography, Buffer systems), taking ownership from mechanical completion through to handover for qualification.

· Lead on-site system setup, shakedown, and performance tuning activities to achieve stable and optimal operation in line with Good Engineering Practice (GEP).

· Verify system readiness for commissioning, ensuring all associated utilities are correctly flushed, purged, and prepared prior to energisation.

· Conduct detailed system and vessel inspections (mechanical integrity, hygienic standards, and cleanliness), ensuring alignment between as-built systems and design specifications.

· Troubleshoot and resolve complex technical issues, including misalignments, leaks, control instabilities, and equipment or instrumentation faults.

· Ensure all shakedown and commissioning activities are executed in accordance with GEP requirements and site safety procedures, including COHE/LOTO where applicable.

· Coordinate closely with Automation Engineers (e.g. DeltaV/PLC) to support interlock testing, I/O verification, and alarm functionality during system start-up.

· Interface with Utilities, HVAC, vendors, and construction teams to ensure effective integration and issue resolution across system boundaries.

· Support commissioning documentation, including test records, punch list management, and system turnover packages to C&Q teams.

· Provide technical support and guidance to junior engineers and technicians during commissioning and shakedown activities.

· Support deviation resolution, field changes, and issue tracking to ensure systems are delivered in line with project timelines and quality expectations.

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.