Process Lead Engineer - CIP/SIP & GMP Automation
NO DEVIATION PTE. LTD.
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Job summary
No deviation is seeking a Process Lead Engineer to provide technical leadership for pharmaceutical manufacturing operations. The role focuses on CIP, SIP, washers and autoclaves, with collaboration across MS&T, Engineering, Automation and Operations to ensure compliant, reliable production.
The candidate will support equipment qualification, design reviews, risk assessments and continuous improvement initiatives, while driving process optimization and troubleshooting across the site.
Qualifications
- Degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Biotechnology or another relevant engineering discipline.
- Strong process engineering experience within a pharmaceutical, biologics or GMP manufacturing environment.
- Hands-on experience with CIP and SIP systems is highly preferred.
- Good working knowledge of equipment such as: Parts / equipment washers, Autoclaves, Process vessels, Clean utilities, Automated process equipment.
- Experience supporting IQ/OQ/PQ, FAT, SAT, commissioning and validation activities.
- Experience with change control, deviation investigations and CAPA management.
- Strong understanding of P&IDs, URS, process risk assessments and HAZOP.
- Experience working with Automation and MS&T teams and translating process requirements into automation recipes and parameters.
- Strong process troubleshooting and root cause analysis capability.
- Able to independently identify technical problems and develop practical engineering solutions.
Responsibilities
- Provide technical ownership and engineering support for CIP, SIP, washers, autoclaves and associated process systems.
- Develop and maintain process engineering documentation throughout the equipment and process lifecycle.
- Support process and equipment design activities, including: P&ID development and review, URS, SRA, FRA, Design Reviews/Qualification, HAZOP and other risk assessments.
- Provide technical support for equipment modifications, upgrades and improvement initiatives.
- Lead engineering-related continuous improvement initiatives to improve process reliability and efficiency.
- Lead complex process and engineering troubleshooting beyond frontline operations.
- Drive optimisation of processes such as CIP/SIP cycles and equipment operating parameters.
- Provide independent technical support to ensure smooth day-to-day site operations.
- Act as a bridge between MS&T and Automation teams for translating process requirements into automation recipes and parameters.
- Support change controls, deviations, CAPAs and technical investigations.
Skills
Education
Job description
No deviation is seeking a Process Lead Engineer to provide technical leadership for pharmaceutical manufacturing operations. The role focuses on CIP, SIP, washers and autoclaves, with collaboration across MS&T, Engineering, Automation and Operations to ensure compliant, reliable production.
The candidate will support equipment qualification, design reviews, risk assessments and continuous improvement initiatives, while driving process optimization and troubleshooting across the site.
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