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Senior Consultant - Drug Substance Engineering

  • Full Time
  •  On-Site - Mumbai Metropolitan Region
  • 6 months
  • Project posted on: 19/11/2025
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Senior Consultant - Drug Substance Engineering

  • Engineering Services
  • Chemical engineering

On-Site - Mumbai Metropolitan Region, Delhi / NCR, Kolkata, Chennai, Bengaluru, Bengaluru, Pune, Hyderabad, Kuala Lumpur, Malaysia, George Town (Penang), Malaysia, Johor Bahru, Malaysia

Full Time

6 months

 19/11/2025

Assignment Details

Our client, Our client, An Indian biopharmaceutical company, is looking for a Senior Consultant - Drug Substance Engineering for their Malaysia location. 

 

Roles and Responsibilities:

   

  • Lead and manage all engineering & maintenance activities for the Drug Substance facility.
  • Ensure zero unplanned downtime through effective preventive and predictive maintenance programs.
  • Oversee calibration, validation, qualification (IQ/OQ/PQ) and ensure timely closure as per annual planners.
  • Implement and enforce GMP, GEP, EHS and quality compliance across all engineering operations.
  • Manage plant equipment performance, troubleshoot issues, and support uninterrupted manufacturing operations.
  • Drive engineering investigations, deviations, CAPA, and change controls.
  • Lead brownfield/greenfield projects, equipment upgrades, and process optimization initiatives.
  • Review and approve engineering documentation, reports, SOPs, and maintenance records.
  • Plan and manage CAPEX & OPEX budgets, ensuring cost-effective operations without compromising quality.
  • Maintain critical spares inventory and ensure high equipment reliability.
  • Mentor and develop engineering teams; implement training and capability development plans.
  • Collaborate with Drug Product, Utility, R&D and Facility teams for cross-functional engineering support.
  • Ensure accurate reporting and communication of key engineering metrics to senior management.

Skills Required

  • Bachelor’s or Master’s degree in Engineering 
  • 15+ years of experience in pharmaceutical/biopharmaceutical engineering, with focus on injectables or sterile manufacturing.
  • Strong background in Drug Substance / API / Biologics manufacturing.
  • Proven experience in engineering maintenance, validation, and equipment reliability.
  • Prior experience in leading engineering teams at a plant or site level.
  • Certification or training in GMP, GEP, EHS, or Quality Systems (preferred).
  • Experience with SAP or CMMS systems (advantage).
  • Exposure to commissioning, qualification, FAT/SAT, and large-scale engineering projects.

About the Client

An Indian biopharmaceutical company manufacturing generic active pharmaceutical ingredients that are sold in over 120 countries across the globe

Industry

Pharmaceuticals

Experience Required:

15+ years

Additional Skills:

  • CAPEX & OPEX Management
  • CAPEX
  • EHS Compliance
  • Preventive & Predictive Maintenance
  • Drug Substance Engineering
  • Sterile Operations
  • Injectables Operations
  • Engineering Maintenance
  • Drug Substance
  • OPEX
  • HVAC
  • Pharmaceutical Engineering
  • CAPEX Management
  • Plant Maintenance Operations
  • Process Optimization
  • GMP
  • EHS
  • Equipment Qualification
  • Pharma
  • cGMP
  • Pharma Production Support
  • Good Engineering Practices
  • Injectable Manufacturing
  • Calibration & Validation
  • SAP Maintenance Management
  • Pharma Manufacturing Equipment
  • Preventive Maintenance
  • Operational Management System
  • GEP

No of open positions:

1

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