18 Oct
|
Anthea Pharma
|
Hyderabad
18 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