Senior Manager Engineering (OSD Facility)

Acme Formulation · Nalagarh, India

Key Responsibilities

1. Lead the operation, maintenance, and reliability of HVAC, Water Systems, Utilities, and Process Equipment.
2. Plan, execute, and monitor preventive, predictive, and breakdown maintenance activities.
3. Ensure compliance with cGMP, GEP, GDP, and regulatory requirements across all engineering operations.
4. Review, approve, and implement SOPs, engineering documents, and departmental procedures.
5. Drive qualification and validation activities (DQ/IQ/OQ/PQ) in coordination with User Departments and QA.
6. Ensure compliance with electronic systems including Caliber e-Log, LMS, BMS, EDCS, and eQMS.
7. Lead internal audits, self-inspections, and ensure timely closure of audit observations and CAPAs.
8. Review APQR inputs and support continuous process and equipment improvements.
9. Analyze critical equipment failures, conduct root cause analysis, and implement preventive measures to improve reliability.
10. Lead commissioning, installation, and qualification of new equipment, utilities, and facility modifications.
11. Plan and implement engineering projects, automation initiatives, and facility upgrades.
12. Review and approve engineering documentation, maintenance records, protocols, reports, and change controls.
13. Ensure effective management of engineering deviations, incidents, CAPAs, change controls, and risk assessments.
14. Monitor engineering alarms, excursions, and critical utility performance to ensure uninterrupted operations.
15. Maintain optimum spare parts inventory and vendor management for critical equipment.
16. Coordinate with Production, QA, QC, Validation, and EHS for smooth execution of engineering activities.
17. Drive implementation of engineering safety standards and statutory compliance across the facility.
18. Lead manpower planning, recruitment, training, performance management, and competency development of the Engineering and EHS teams.
19. Support and represent the Engineering function during regulatory and customer audits (USFDA, MHRA, EU, WHO, etc.).
20. Ensure compliance and operational excellence of all Engineering and EHS activities within the OSD manufacturing facility.

Desired Competencies

• Strong knowledge of HVAC, Water Systems (PW/WFI where applicable), Utilities, and Process Equipment.
• Expertise in Qualification & Validation, Maintenance Management, and Engineering Compliance.
• Sound understanding of cGMP, GEP, GDP, 21 CFR Part 11, Data Integrity, and regulatory expectations.
• Experience with BMS, EMS, SCADA, PLC/Automation systems, and computerized maintenance systems.
• Excellent leadership, project management, vendor management, and cross-functional coordination skills.
• Proven experience in handling regulatory inspections and driving engineering compliance initiatives.

Qualification: B.Tech (Mechanical/Electrical/Instrumentation or equivalent)

Experience: 18+ years in a USFDA-approved OSD pharmaceutical manufacturing facility