Key Responsibilities
- Ensure trouble-free operation and maintenance of process and utility equipment.
- Plan and monitor preventive maintenance activities to minimize downtime.
- Handle equipment breakdowns, RCA, and CAPA implementation.
- Lead equipment qualification, validation, calibration, and requalification activities.
- Review SOPs, protocols, reports, technical documents, and validation records.
- Manage engineering compliance with cGMP and regulatory requirements.
- Coordinate with cross-functional teams for projects, modifications, and engineering support.
- Monitor spare inventory and ensure availability of critical spares.
- Ensure adherence to EHS requirements and work permit systems.
- Prepare technical evaluations, cost estimates, and techno-commercial comparisons for projects.
Technical Requirements
- Hands-on experience in sterile manufacturing and filling equipment.
- Good understanding of aseptic practices, cleanroom behavior, and GMP documentation.
- Ability to independently manage shop-floor engineering activities.
Mandatory Equipment Exposure
- Filling Lines (B+S, Bosch, Groninger, IMA, Tofflon, Optima, Truking, Steriline, etc.)
- Lyophilizers
- Autoclaves
- Manufacturing & Holding Vessels
Qualification:
- Diploma / B.Tech in Electrical or Instrumentation Engineering
Experience:
- 8–14 years in sterile injectable pharmaceutical manufacturing.
Preferred
- Candidates from sterile injectable facilities.
- Immediate joiners or candidates with short notice periods.
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