Senior C&Q/Shakedown Engineer

CAI; Limerick; On-site; EUR 70,000 - 90,000; Full time

Job summary

CAI is seeking a Senior C&Q Engineer in Limerick to support commissioning activities on a high-profile biopharma project. This role will require execution, optimisation, and stabilisation of bioprocessing systems. You will act as the Commissioning SME, leading system setup and performance tuning, supported by a strong background in GMP, FDA/EMA regulations, and substantial bioprocess experience. Must be flexible for travel and commit to a minimum 40-hour work week.

Qualifications

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

Responsibilities

• Lead commissioning activities for equipment packages.
• Conduct system inspections and ensure mechanical integrity.
• Troubleshoot complex technical issues during commissioning.

Skills

GMP requirements knowledge

Hands-on upstream and downstream bioprocess knowledge

Documentation and communication skills

Stakeholder engagement skills

Education

Degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline

Tools

Bioreactors

Filtration systems

CIP/SIP systems

Job description

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 hand‑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.