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.

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.

Manager – Automation, Instrumentation, Calibrations, Equipment Maintenance

Key skills