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Manager - Plant Engineering, Pharma Formulations

Manager - Plant Engineering, Pharma Formulations

ConfidentialAnkleshwar, India
5 days ago
Job description

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.

    Skills Required

    Root Cause Analysis, Spare Parts Management, Fda, Breakdown Maintenance, Cgmp, Sops, Iso, Capex, Team Leadership, Energy Efficiency, Opex, equipment qualification , Project Management, engineering documentation , Cost Reduction, Mechanical Engineering

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    Plant Manager • Ankleshwar, India

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