Senior C&Q/Shakedown Engineer

Job Description: Senior C&Q/Shakedown Engineer

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.

· 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.

• 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

• 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.