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Onsite Manager – Automation, Instrumentation, Calibrations, Equipment Maintenance
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About the role
- Automation and Calibration Manager leading automation and calibration in a GMP facility in Singapore. Implementing maintenance strategies and ensuring regulatory compliance.
Responsibilities
- Lead project automation packages’ implementation of Building Management System (BMS)/ Environmental Management System (EMS) / Process automation.
- Review automation system design for all package equipment, Factory Acceptance Test (FAT) / installation/ Site Acceptance Test (SAT) commissioning/ validation.
- People management includes to automation and calibration team establishment, training, subordinate goal setting, and performance evaluation.
- Create and update automation SOP/ WI and other operation documentation.
- Ensure department GMP procedures are in compliance with relevant company policies and regulatory requirements.
- Facilitate execution of related Out of specification (OOS) and Out of Trend (OOT), deviations, Corrective and preventive action (CAPA), etc. related to quality.
- Act as automation Subject Matter Expect (SME) during customer and regulatory audit.
- Support plant operation including automation and instrument’s spare part management, troubleshooting via on call or on site.
- Manage the automation related OPEX and CAPEX budget, lead and implement the site driven automation projects.
Requirements
- Bachelor's Degree in Engineering
- Minimum 8-10 years of relevant experience in Bio-pharmaceutical industry
- Experience in managing a team of engineers and technicians
- Expert knowledge of cGMP requirements and regulatory standards (FDA, EMA)
- Strong understanding of electrical, Instrumentation, hydraulic, and pneumatic systems
- Demonstrated experience with preventive & corrective maintenance programs
- Demonstrated ability to develop and implement maintenance strategies and KPIs
- Experience managing equipment qualification and validation processes
- Strong project management and budget planning capabilities
- Effective cross-functional collaboration and stakeholder management
- Strong problem-solving and analytical skills
- Clear verbal and written communication abilities
- Available for on-call rotation and emergency response
- Proficiency with Microsoft Office suite and maintenance management systems
- Commitment to safety and environmental health standards
- Ability to work in clean room environments and comply with GMP requirements
- Physical requirements include standing, walking, and occasional lifting up to 40 pounds.
Benefits
- Health insurance
- Professional development opportunities
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