- Plant Maintenance: Manage preventive and breakdown maintenance of API equipment (Reactors, Centrifuges, ANFDs, RCVDs).
- Utility Operations: Oversee critical utilities, including HVAC (Cleanrooms), Purified Water (PW) systems, Chillers, and Boilers.
- Regulatory Compliance: Act as the primary engineering lead to face and defend USFDA and EDQM regulatory audits.
- Engineering QMS: Draft and manage engineering Change Controls, Deviations, CAPAs, and audit trails.
- Validation & Safety: Oversee the equipment qualification lifecycle (DQ/IQ/OQ/PQ) and enforce strict EHS / LOTO safety standards.
Preferred candidate profile
15 to 20 years in pharma, with 5+ years leading maintenance in a USFDA-Approved API facility.