Sipra Labs Limited
Facility Manager at Sipra Labs Limited in Hyderabad
ExperiencedOn-siteHyderabad500000 INR–800000 INR/yr
Skills
Facility OperationsUtility MaintenanceHVAC MaintenanceEHSUSFDAAmcsFacility AdministrationVendor Management
Job Description
The role requires ensuring uninterrupted laboratory operations, regulatory compliance, EHS standards, and audit readiness in a US FDA-regulated environment.
Key Responsibilities:
- Manage end-to-end facility operations, including HVAC, chilled water, compressed air, purified water, DG sets, UPS, electrical distribution, plumbing, and fire systems.
- Plan and execute preventive and breakdown maintenance to ensure zero unplanned downtime across laboratory facilities.
- Maintain facility qualification status (IQ/OQ/PQ and requalification) and environmental controls in compliance with US FDA, NABL, and GLP requirements.
- Manage AMC contracts, vendor performance, spare-part inventory, and facility CapEx/OpEx budgets.
- Maintain audit-ready documentation, including logbooks, temperature, humidity, differential pressure records, breakdown logs, and deviation records as per ALCOA+ data integrity principles.
- Ensure statutory compliance related to Electrical Inspectorate, Fire NOC, Pollution Control Board, lifts, pressure vessels, water, and effluent management.
- Lead Environment, Health & Safety (EHS) activities, including safety audits, mock drills, PPE compliance, incident investigations, and CAPA closure.
- Supervise the maintenance team, housekeeping, and security contractors, ensuring effective training and shift coverage.
- Support client audits, US FDA inspections, and NABL assessments, and ensure timely closure of facility observations.
- Drive energy efficiency, cost optimization, and operational improvement initiatives.
Desired Candidate Profile:
- 7 - 12 years of experience in facility management or engineering maintenance.
- Minimum 5 years of experience in a regulated Pharmaceutical, CRO, Biotech, or Laboratory environment.
- Strong knowledge of HVAC systems, clean utilities, electrical and facility maintenance.
- Hands-on experience with US FDA, NABL ISO 17025, and OECD GLP facility compliance requirements.
- Experience managing AMC contracts, vendors, budgeting, and statutory compliance.
- Strong leadership, documentation, and stakeholder management skills.
- Prior exposure to a US FDA-inspected site will be an added advantage.