Job Description
Our client in Limerick are seeking an highly-experienced commissioning engineer to oversee process equipment packages, onsite setup, shakedown, and performance optimization of their systems. This role is central to developing and executing sourcing strategies for direct material in the Drug Substance, Drug Products and Packaging CMO categories. The successful candidate will develop category strategies and lead cross-functional sourcing projects, align market intelligence with business needs, and drive supplier selection.
Key Responsibilities
* Oversee a package as commissioning SME e.g. Bioreactor package work with the associated C&Q/Auto/Vendor engineers assigned to a specific system
* Perform onsite setup and shakedown of new systems and equipment to ensure functionality and readiness for commissioning.
* Fine-tune equipment and systems to achieve optimal performance, including adjustments to process parameters.
* Take part and ensure associated utilities are flushed/purge/blown down
* Vessel inspections
* Troubleshoot and resolve technical issues, such as equipment misalignments, system instability, or operational inefficiencies.
* Ensure systems are operating within design tolerances and specifications.
* Work closely with process engineers and operations teams to establish baseline performance data for equipment and systems.
* Verify alignment of shakedown activities with Good Engineering Practices (GEP) to prepare systems for GMP compliance.
* Coordinate with vendors and contractors onsite to address equipment-specific issues and finalize system readiness.
* Ensure compliance with all safety protocols and site-specific standards during shakedown activities.
* Prepare systems for commissioning by ensuring all equipment and processes are stabilized and meet operational requirements.
Key Requirements
* Minimum of 7 years of experience in shakedown and tuning of systems and equipment in a regulated biopharma or pharmaceutical environment.
* Proven expertise in optimizing and stabilizing systems under GEP frameworks.
* Familiarity with construction oversight and COHE implementation, controls and plans.
* Proficiency in interpreting engineering drawings, P&IDs, and technical documentation.
* Strong knowledge of biopharma equipment and systems (e.g., bioreactors, chromatography columns, filtration units, utilities).
* Expertise in troubleshooting and resolving mechanical, electrical, and automation issues onsite.
* Familiarity with process control systems and instrumentation adjustments.
* Familiarity with process control systems (e.g., DeltaV, PLCs) and automation systems.
* Strong analytical and problem-solving abilities.
* Excellent communication and interpersonal skills for cross-functional collaboration.
* Ability to work under pressure and meet strict deadlines.
Benefits
* Competitive and attractive employee compensation package
* Pension contributions
* Health insurance
* Paid public holidays
Location: Limerick, Ireland | onsite
Desired Skills and Experience
Key Responsibilities
Oversee a package as commissioning SME e.g. Bioreactor package work with the associated C&Q/Auto/Vendor engineers assigned to a specific system
Perform onsite setup and shakedown of new systems and equipment to ensure functionality and readiness for commissioning.
Fine-tune equipment and systems to achieve optimal performance, including adjustments to process parameters.
Take part and ensure associated utilities are flushed/purge/blown down
Vessel inspections
Troubleshoot and resolve technical issues, such as equipment misalignments, system instability, or operational inefficiencies.
Ensure systems are operating within design tolerances and specifications.
Work closely with process engineers and operations teams to establish baseline performance data for equipment and systems.
Verify alignment of shakedown activities with Good Engineering Practices (GEP) to prepare systems for GMP compliance.
Coordinate with vendors and contractors onsite to address equipment-specific issues and finalize system readiness.
Ensure compliance with all safety protocols and site-specific standards during shakedown activities.
Prepare systems for commissioning by ensuring all equipment and processes are stabilized and meet operational requirements.
Minimum of 7 years of experience in shakedown and tuning of systems and equipment in a regulated biopharma or pharmaceutical environment.
Proven expertise in optimizing and stabilizing systems under GEP frameworks.
Familiarity with construction oversight and COHE implementation, controls and plans.
Proficiency in interpreting engineering drawings, P&IDs, and technical documentation.
Strong knowledge of biopharma equipment and systems (e.g., bioreactors, chromatography columns, filtration units, utilities).
Expertise in troubleshooting and resolving mechanical, electrical, and automation issues onsite.
Familiarity with process control systems and instrumentation adjustments.
Familiarity with process control systems (e.g., DeltaV, PLCs) and automation systems.
Strong analytical and problem-solving abilities.
Excellent communication and interpersonal skills for cross-functional collaboration.
Ability to work under pressure and meet strict deadlines.