Job Description

Key Responsibilities

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

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

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

📌 Senior Manager Engineering (OSD Facility) (Kaundi)
🏢 Acme Formulation
📍 Kaundi