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.
 and KEY ACCOUNTABILITIES
Engineering & Maintenance OperationsOversee 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 & DocumentationEnsure 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 ManagementPlan 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 ImprovementDrive energy efficiency, cost reduction, and reliability improvement initiatives.
Implement Kaizen methodologies.
Monitor KPIs such as OTIF, OEE, MTBF, MTTR, and maintenance cost.
Team LeadershipLead 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 / LanguagePlanning 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.               
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