Senior Manager Engineering (OSD Facility)

Acme Formulation · Himachal Pradesh, India

Key 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.

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