AMN Life Science Pvt. Ltd.
Website:
amnlife.com
Job details:
AMN life Science Pvt Ltd is Hiring Manager – Engineering Department
Function: Engineering, Utilities & Facilities
Location: Vapi (Gujarat)
Reporting To: Plant Head / Director – Operations
Plant Type: EU-GMP Approved (OSD & Injectable)
Job Purpose
To lead and manage engineering operations for OSD and Sterile Injectable manufacturing facilities, ensuring EU-GMP and Annex 1 compliance, high equipment reliability, safe operations, timely execution of projects, and continuous improvement in efficiency and sustainability.
Key Responsibilities Engineering Leadership & Maintenance
- Head overall engineering, utilities, calibration, and facility management.
- Ensure robust preventive, predictive, and breakdown maintenance systems.
- Drive equipment uptime, reduce breakdowns, and improve OEE.
- Implement and maintain CMMS, spare part management, and asset lifecycle controls.
EU-GMP & Regulatory Compliance
- Ensure full compliance with EU-GMP, WHO-GMP, MHRA, and Annex 1 (Sterile Manufacturing).
- Lead DQ, IQ, OQ, PQ of equipment, utilities, cleanrooms, and facilities.
- Support regulatory inspections, customer audits, and CAPA execution.
- Maintain engineering change controls, deviations, and risk assessments.
OSD-Specific Responsibilities
- Manage and maintain OSD equipment including:
- Granulation (RMG, FBD), blending, compression, coating
- Blister, strip, and bottle packaging lines
- Ensure HVAC compliance for classified areas, pressure differentials, and temperature/humidity control.
- Implement dust extraction, containment, and cross-contamination control systems.
- Improve cleaning efficiency, changeover times, and line clearance readiness.
Injectable-Specific Responsibilities
- Lead engineering for aseptic and sterile manufacturing areas:
- Cleanrooms (Grade A/B/C/D), LAF, RABS, isolators
- Oversee critical sterile utilities:
- WFI, Pure Steam, Clean Compressed Air, Nitrogen
- Ensure strict adherence to Annex 1 & Contamination Control Strategy (CCS).
- Manage sterilization systems:
- Autoclaves, depyrogenation tunnels, sterilizing filters
- Support media fills, aseptic process simulations, and EM readiness.
Utilities & Facility Management
- Oversee utilities including:
- HVAC systems (OSD & Sterile)
- Electrical systems, DG sets, UPS
- Boilers, chillers, compressors
- Ensure compliance with statutory, safety, fire, and environmental norms.
- Drive energy conservation and sustainability initiatives.
CAPEX, Projects & Technology Transfer
- Lead CAPEX planning, budgeting, and execution.
- Manage FAT, SAT, installation, commissioning, and validation of new equipment.
- Support new product introductions and technology transfers.
- Coordinate with vendors, consultants, and cross-functional teams.
People & Cost Management
- Build, mentor, and lead high-performing engineering teams.
- Control maintenance and utility costs without compromising compliance.
- Develop SOPs, training programs, and succession planning.
Qualifications & Experience
- B.E./B.Tech – Mechanical / Electrical / Instrumentation Engineering
- 15–20+ years of experience in pharmaceutical engineering
- 5–7+ years in a leadership role in EU-approved OSD & Injectable plants
Salary Range- 11-13 LPA
Please feel free to connect @8976869261 and share your CV at shankar.sahu@amnlife.com/hr@amnlife.com
Click on Apply to know more.