Job Title
Manager - Plant Engineering, Pharma Formulations
Plant Maintenance Pharma Formulations
Basic & Minimum Qualification
Degree in Mechanical Engineering from a reputed university.
Experience
12 to 15 years of working experience in a Pharmaceutical Formulations plant.
Location: Ankleshwar Site.
Job Description And KEY ACCOUNTABILITIES
Engineering & Maintenance Operations
- Oversee preventive, predictive, and breakdown maintenance of plant equipment and infrastructure.
- Ensure optimal performance of manufacturing & packing, and warehouse equipment.
- Lead root cause analysis and corrective actions for equipment failures.
- Documentation and maintaining the History cards of all critical plant equipment.
Compliance & Documentation
- 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.
Project Management
- Plan and execute capital projects, including equipment installation, facility upgrades, and expansions.
- Prepare and manage engineering budgets (CAPEX & OPEX).
- Coordinate with cross-functional teams for timely project delivery.
Continuous Improvement
- Drive energy efficiency, cost reduction, and reliability improvement initiatives.
- Implement Kaizen methodologies.
- Monitor KPIs such as OTIF, OEE, MTBF, MTTR, and maintenance cost.
Team Leadership
- 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.
- Preparation and implementation of standard operating procedures for Plant Engineering operations and documentation of the same.
- Spare parts management Responsible for procuring spare parts and maintaining stock for all critical equipment.
- Responsible for complying with the suggestions given by the HSE Cell.
- Responsible for complying with recommendations made by the internal GMP cell
- Responsible for the implementation of cGMP and EH&S requirements for PHARMACEUTICALS.
- Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations.
- Carrying out any other assignments or projects as per the instructions of the Department. Head to meet with the organizational objectives and priorities.
- Performing internal quality as a Qualified Internal Auditor during internal Quality Audit, abiding by the internal quality audit schedule.
Technical Skills & Competencies / Language
- Planning ability
- Collaborative Leadership
- Communication skills (Verbal and Written)
- Strong knowledge of HSE, GMP, validation, and regulatory compliance.
- Proficiency in project management, budgeting, and technical documentation.
- Excellent communication and problem-solving skills.
- Time management.
- Problem solving
Documentation. Adherence to HSE requirements in fulfilling the customer's requirements, Living Group's Values, and Code of Ethics.
