Senior Manager – Engineering (Injectable)

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 Requirement

• 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

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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:14-18 years in sterile injectable pharmaceutical manufacturing.

Preferred Candidates from sterile injectable facilities. Immediate joiners or candidates with short notice periods.