Manager-Automation, Instrumentation, Calibrations & Equipment maintenance

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
The Automation and Calibration Manager will be responsible for leading, implementing and managing all Automation and calibration function of Sterile Drug Products GMP (Good Manufacturing Practice) Filling facility in Singapore. . You'll develop effective maintenance strategies, implement preventive maintenance programs, and ensure regulatory compliance while minimizing equipment downtime. This role offers the opportunity to contribute to our mission of enabling customers to make the world healthier, cleaner, and safer through reliable manufacturing operations. You'll work with cross-functional teams, support maintenance staff development, and implement continuous improvement initiatives to optimize equipment performance and reliability.

Key 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.

Minimum Requirements/Qualifications

• Bachelor's Degree in Engineering with minimum 8-10 years with relevant experiences 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

Competencies ·

• Good knowledge in GMP, Good Automated Manufacturing Practice (GAMP), Data integrity, 21 CFR Part 11, Digitalization, Computer System Validation
• Solid experience in instruments, control systems, network, electrical. Project and operation experience in Programmable Logic Controller (PLC), Direct Digital Controls (DDC), Distributed Control System (DCS), Supervisory Control and Data Acquisition (SCADA).
• Experience in Sterile Drug Product Fill Finish equipment (Filling line package, Lyophilizer, Autoclave) and Clean Room Building Management System (BMS)/ Environmental Management System (EMS), Clean Utility automation experience is preferred.