Key Responsibilities

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n n Lead the operation, maintenance, and reliability of HVAC, Water Systems, Utilities, and Process Equipment.

n Plan, execute, and monitor preventive, predictive, and breakdown maintenance activities.

n Ensure compliance with c GMP, GEP, GDP, and regulatory requirements across all engineering operations.

n Review, approve, and implement SOPs, engineering documents, and departmental procedures.

n Drive qualification and validation activities (DQ/IQ/OQ/PQ) in coordination with User Departments and QA.

n Ensure compliance with electronic systems including Caliber e-Log, LMS, BMS, EDCS, and e QMS.

n Lead internal audits, self-inspections, and ensure timely closure of audit observations and CAPAs.

n Review APQR inputs and support continuous process and equipment improvements.

n Analyze critical equipment failures, conduct root cause analysis, and implement preventive measures to improve reliability.

n Lead commissioning, installation, and qualification of recent equipment, utilities, and facility modifications.

n Plan and implement engineering projects, automation initiatives, and facility upgrades.

n Review and approve engineering documentation, maintenance records, protocols, reports, and change controls.

n Ensure effective management of engineering deviations, incidents, CAPAs, change controls, and risk assessments.

n Monitor engineering alarms, excursions, and critical utility performance to ensure uninterrupted operations.





n Maintain optimum spare parts inventory and vendor management for critical equipment.

n Coordinate with Production, QA, QC, Validation, and EHS for smooth execution of engineering activities.

n Drive implementation of engineering safety standards and statutory compliance across the facility.

n Lead manpower planning, recruitment, training, performance management, and competency development of the Engineering and EHS teams.

n Support and represent the Engineering function during regulatory and customer audits (USFDA, MHRA, EU, WHO, etc.).

n Ensure compliance and operational excellence of all Engineering and EHS activities within the OSD manufacturing facility.

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n Desired Competencies

n n Strong knowledge of HVAC, Water Systems (PW/WFI where applicable), Utilities, and Process Equipment.

n Expertise in Qualification & Validation, Maintenance Management, and Engineering Compliance.

n Sound understanding of c GMP, GEP, GDP, 21 CFR Part 11, Data Integrity, and regulatory expectations.

n Experience with BMS, EMS, SCADA, PLC/Automation systems, and computerized maintenance systems.

n Excellent leadership, project management, vendor management, and cross-functional coordination skills.

n Proven experience in handling regulatory inspections and driving engineering compliance initiatives.

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

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

📌 Senior Manager Engineering (osd Facility) (Nalagarh)
🏢 Acme Formulation
📍 Nalagarh