Manager - Plant Engineering, Pharma Formulations

4 days ago

Ankleshwar, Gujarat, India Zentiva Full time US$ 10,00,000 - US$ 25,00,000 per year

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.

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