We are seeking a highly experienced C&Q/Shakedown Engineer to lead the commissioning and shakedown of bioprocessing equipment packages—including bioreactors, CIP systems, chromatography skids, and buffer preparation systems—in a regulated biopharmaceutical environment. This hands-on role is responsible for ensuring that systems perform to optimal GEP standards, coordinating cross-functionally with utilities, automation, and HVAC teams, and driving issue resolution during project execution.
Responsibilities
Oversee assigned equipment packages as the Commissioning Subject Matter Expert (SME), including Bioreactor, CIP, and related systems.
Perform on-site system setup, shakedown, and performance tuning per Good Engineering Practice (GEP) standards.
Ensure associated utilities are properly flushed, purged, and blown down prior to equipment commissioning.
Conduct detailed vessel inspections (mechanical, hygienic, and cleanliness); verify installed equipment matches design specifications ("as-built vs design").
Troubleshoot and resolve equipment issues such as misalignments, system instability, leaks, and drive or valve faults.
Verify and document all shakedown activities comply with GEP requirements.
Coordinate with Emerson Automation Engineers during interlock checks, I/O signal verification, and alarm testing.
Liaise with on-site Utilities and HVAC teams to ensure seamless interfaces and proper system functionality.
Experience Requirements
Minimum 10 years’ hands-on shakedown and commissioning experience in regulated biopharma or pharmaceutical manufacturing environments.
Demonstrated expertise in stabilising and optimising bioprocessing systems within GEP (Good Engineering Practice) frameworks.
Familiarity with construction oversight, COHE/LOTO (Control of Hazardous Energy/Lock-Out Tag-Out) procedures, and safe energisation protocols.
Experience collaborating with automation teams (DeltaV, PLC) during system commissioning.
Technical Skills
Deep knowledge of Upstream (USP) equipment: bioreactors, media/buffer prep, CIP/SIP systems.
Familiarity with Downstream (DSP) systems: chromatography, filtration units.
Advanced mechanical, electrical, and instrumentation troubleshooting abilities.
Proficiency in interpreting P&IDs, instrument loop diagrams, and electrical schematics.
Practical experience with DeltaV, PLCs, and process measurement/control instrumentation (flow, pressure, temperature, level).
Soft Skills & Behaviours
Strong analytical and problem-solving skills; able to make sound decisions under time constraints.
Excellent communication skills; adept at cross-functional teamwork, especially with automation vendors and utilities teams.
Willingness to work extended hours and weekends as project demands require during critical commissioning periods.
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