Manager - Instrumentation & Automation (Injectables)

Key Responsibilities

• Lead preventive, predictive, and breakdown maintenance of instrumentation and automation systems across manufacturing, utilities, and packaging areas.
• Manage PLC, SCADA, HMI, DCS, BMS, and environmental monitoring interfaces, as applicable.
• Ensure reliable operation of sterile injectable equipment, including vial/ampoule filling lines, autoclaves, sterilization tunnels, lyophilizers, compounding vessels, and CIP/SIP systems.
• Oversee instrumentation for HVAC, cleanrooms, purified water (PW), water for injection (WFI), pure steam, and compressed air systems.
• Manage calibration schedules, instrument criticality assessments, preventive maintenance plans, and spare-parts inventory.
• Ensure GMP compliance, data integrity, and audit readiness in accordance with applicable regulatory requirements, including Indian Schedule M, EU GMP Annex 1, and 21 CFR Part 11, where applicable.
• Lead and support equipment qualification, computerized system validation, FAT/SAT, IQ/OQ, change control, deviation investigations, CAPA, and risk assessments.
• Ensure proper management of electronic records, audit trails, user access, system backups, and automation software changes.
• Coordinate with Production, QA, QC, Validation, IT, Project Engineering, and OEMs for troubleshooting, upgrades, commissioning, and continuous improvement.
• Lead the instrumentation and automation team, manage departmental budgets, and drive reliability improvement initiatives.

Educational Qualification & Experience

• B.E./B.Tech. in Instrumentation, Electronics, Electrical Engineering with minimum 12+ years of relevant experience in pharmaceutical manufacturing, preferably in sterile injectable/parenteral facilities.
• Strong hands-on experience in instrumentation maintenance, PLC/SCADA systems,calibration, qualification, validation, and GMP documentation.
• Experience in aseptic manufacturing equipment, clean utilities, regulatory audits, and team management is essential.