Engineering Department Manager

AMN life Science Pvt Ltd is Hiring Manager

Function:

Location: Kala Amb ( Himachal Pradesh)

Reporting To:

Plant Type:

Job Purpose

OSD and Sterile Injectable manufacturing facilities

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