GM Engineering -Vadodara.
Job Description:
Amoli Organics Pvt Ltd - GM Engineering -Vadodara.
Designation: General Manager – Engineering (API Plant)
-
Location: Vadodara, Gujarat, India - (JFYI ... In future he will also take care Vapi Unit).
- Department: Engineering & Maintenance
- Reporting To: Plant Head / Vice President /President– Operations
- Supervises: Maintenance Managers, Utility Engineers, Instrumentation & Automation Teams, Project Engineers, and EHS Engineering.
Job Purpose
To lead, direct, and oversee all plant engineering activities, including project execution (CAPEX), routine and preventive maintenance, utility management, and calibration systems. The incumbent ensures 100% equipment reliability, uninterrupted high-purity utility supply, and strict adherence to global regulatory standards (USFDA, MHRA, EDQM) and local statutory norms while optimizing costs.
Key Responsibilities
Must be well versed with the Regulatory Audit requitements & compliances.
1. Regulatory Compliance & Validation
- Ensure the engineering department is permanently audit-ready for inspections by USFDA, MHRA, EDQM, WHO, and local authorities.
- Oversee validation lifecycle activities: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and utilities.
- Enforce strict Good Engineering Practices (GEP) and Good Manufacturing Practices (cGMP) in line with 21 CFR Part 11 for automated systems.
- Manage engineering-related deviations, Change Controls, and Corrective and Preventive Actions (CAPA).
2. Plant Maintenance & Asset Reliability
- Implement advanced maintenance strategies (Preventive, Predictive, and Breakdown) to minimize batch cycle delays and equipment downtime.
- Oversee the maintenance of core API equipment: Glass-Lined Reactors (GLR), Stainless Steel Reactors (SSR), Centrifuges, Agitated Nutsche Filter Dryers (ANFD), VTDs, and Micronizers.
- Drive Reliability Centered Maintenance (RCM) and Total Productive Maintenance (TPM) methodologies across production blocks.
3. Critical Pharma Utilities Management
- Ensure uninterrupted generation and distribution of high-purity utilities: Purified Water (PW), Water for Injection (WFI), Pure Steam, Compressed Air, Nitrogen, and Chilled Water.
- Manage non-critical utilities: Multi-stage boilers, cooling towers, and diesel generator sets.
- Optimize Effluent Treatment Plant (ETP), Zero Liquid Discharge (ZLD) plants, and MEE operations in strict compliance with GPCB norms.
4. CAPEX & Project Engineering
- Formulate, seek approval for, and execute the annual Capital Expenditure (CAPEX) budget.
- Lead brownfield expansions, production block modifications, and debottlenecking projects from conceptual design through commissioning.
- Manage vendor selection, contract negotiations, detailed engineering consulting, and procurement of new plant machinery.
5. Automation, Instrumentation & Energy Conservation
- Oversee the plant's automation infrastructure, including DCS (Distributed Control Systems), PLC-SCADA setups, and Building Management Systems (BMS).
- Drive cost-saving and energy-conservation initiatives (power, steam, water) to minimize the plant's overall carbon footprint and operating expenses.
Candidate Profile & Qualifications
Education
- Minimum: B.E. / B.Tech in Mechanical Engineering
Experience
- Overall: 18 to 25 years of progressive experience in pharmaceutical engineering.
Company Profile
Company has been working collaboratively with some of the leading global healthcare players since 3 decades. Strength comes from our expertise in process chemistry further bolstered by our EDQM and USFDA approved facilities allowing us to cater to the needs of the pharmaceutical industry globally.
Apply Now
- Interested candidates are requested to apply for this job.
- Recruiters will evaluate your candidature and will get in touch with you.