Manager - Plant Engineering Pharma Formulations
Location: Ankleshwar Site, Ankleshwar, Gujarat, India. Job Type: Full-time. Role Level: Mid-Level.
Overview
Position for a Manager - Plant Engineering in Pharma Formulations with responsibility for engineering and maintenance operations, compliance, project management, continuous improvement, and team leadership.
Responsibilities
- Oversee preventive, predictive, and breakdown maintenance of plant equipment and infrastructure to ensure optimal performance of manufacturing, packaging, and warehouse equipment.
- Lead root cause analysis and implement corrective actions for equipment failures; document and maintain history cards for all critical plant equipment.
- Ensure compliance with cGMP, FDA, ISO, and other regulatory standards; maintain engineering documentation including SOPs, validation protocols, and equipment qualification records.
- Support audits and inspections by regulatory bodies.
- Plan and execute capital projects, including equipment installation, facility upgrades, and expansions; prepare and manage engineering budgets (CAPEX & OPEX).
- Coordinate with cross-functional teams to ensure timely project delivery.
- Drive energy efficiency, cost reduction, and reliability improvement initiatives; implement Kaizen methodologies.
- Monitor KPIs such as OTIF, OEE, MTBF, MTTR, and maintenance cost.
- Lead and mentor a team of engineers, technicians, and contractors; develop training programs for technical staff; foster a culture of safety, quality, and continuous improvement.
- Prepare and implement standard operating procedures for Plant Engineering operations and maintain related documentation.
- Spare parts management – procure spare parts and maintain stock for all critical equipment.
- Ensure compliance with HSE Cell and internal GMP cell recommendations; implement cGMP and EH&S requirements for pharmaceuticals.
- Identify and correct unsafe conditions or behaviors and promptly report hazardous situations.
- Perform internal quality audits as a Qualified Internal Auditor in accordance with the internal quality audit schedule.
Qualifications
- Degree in Mechanical Engineering from a reputed university.
- 12 to 15 years of working experience in a Pharmaceutical Formulations plant.
- Strong knowledge of HSE, GMP, validation, and regulatory compliance.
- Proficiency in project management, budgeting, and technical documentation; excellent verbal and written communication; time management and problem-solving skills.
Job Details
- Country: India
- City: Ankleshwar, Gujarat
- Job Function: Engineering and Information Technology
- Industry: Pharmaceutical Manufacturing
- Employment Type: Full-time
About The Company
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