19 Oct
|
Anthea Pharma
|
Hyderabad
19 Oct
Anthea Pharma
Hyderabad
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.
Robust 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.
📌 Manager Instrumentation & Automation Injectables Hyderabad
🏢 Anthea Pharma
📍 Hyderabad