Freelance Lead Consultant - Drug Substance

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.