14 Aug
|
SIPRA LABS
|
Hyderabad
14 Aug
SIPRA LABS
Hyderabad
Sipra Labs Limited, a US FDA-approved Contract Research Organisation serving the Pharmaceutical, Biotech and Medical Devices industries for over 30 years, invites applications for the position of Facility Manager at its Hyderabad campus.
Role & responsibilities:
- Own end-to-end facility operations covering HVAC, chilled water, compressed air, purified water, DG sets, UPS, electrical distribution, plumbing and fire systems.
- Plan and execute the preventive maintenance calendar and ensure zero unplanned downtime to the Analytical, Microbiology, Food and Pre-Clinical laboratories.
- Maintain facility qualification status (IQ/OQ/PQ and requalification) and environmental controls in line with US FDA 21 CFR Part 211.42 and 211.46, NABL ISO 17025 Clause 6.3 and OECD GLP facility requirements.
- Manage AMC contracts, vendor performance, spare-part inventory and facility CapEx and OpEx budgets.
- Maintain audit-ready facility records including logbooks, temperature, humidity and differential pressure trends, breakdown and deviation records under ALCOA+ data-integrity principles.
- Own statutory facility compliance covering electrical inspectorate, fire NOC, pollution control board, lift and pressure vessel certifications,
water and effluent management.
- Lead EHS at site through safety audits, mock drills, PPE compliance, incident investigation and CAPA closure.
- Supervise the maintenance team along with housekeeping and security contractors, and drive training and shift coverage.
- Support client audits, US FDA inspections and NABL assessments as facility subject matter expert and close facility observations within timeline.
- Drive energy-efficiency and cost-reduction initiatives contributing to divisional operational-efficiency targets.
Preferred candidate profile
B.E. or B.Tech in Mechanical, Electrical or EEE, or a Diploma with equivalent experience. 7 to 12 years in facility or engineering maintenance, with a minimum of 5 years in a regulated pharmaceutical, CRO or laboratory environment. Prior exposure to a US FDA-inspected site is preferred. Robust working knowledge of clean-utility and HVAC systems, regulatory facility expectations under FDA, NABL and GLP, AMC and vendor negotiation, budgeting, EHS systems, team leadership and documentation discipline.Role & responsibilities
Preferred candidate profile
📌 Facility Manager (Hyderabad)
🏢 SIPRA LABS
📍 Hyderabad