Senior Manager Engineering (OSD Facility)

Acme Formulation; Solan; On-site; INR 1,200,000 - 2,500,000; Full time

Job summary

Acme Formulation in Solan, Himachal Pradesh, India seeks an experienced Engineering Lead to oversee HVAC, water systems, utilities, and process equipment, ensuring cGMP compliance and reliability across manufacturing operations.

You will drive qualification, calibration, and validation activities, manage CAPAs, audits, change controls, and calibration of electronic systems. Strong leadership and cross‑functional collaboration are essential for site-wide engineering excellence.

Responsibilities

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

Job description

Role & 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.

Preferred candidate profile