12 Aug
|
Acme Formulation
|
India
12 Aug
Acme Formulation
India
Job DescriptionKey Responsibilities
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- 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 cGMP, GEP, GDP, and regulatory requirements across all engineering operations. N
- Review, approve, and implement SOPs, engineering documents, and departmental procedures. N
- Drive qualification andvalidation 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 eQMS. 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 ofengineering 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 Enginee
📌 Senior Manager Engineering (India)
🏢 Acme Formulation
📍 India