Acme Formulation
Website:
acmeformulation.com
Job details:
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
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