Freelance- Senior Consultant

3 days ago

Kuala Lumpur, Kuala Lumpur, Malaysia Flexing It® Full time

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.

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