Manager - Plant Engineering, Pharma Formulations bei Zentiva

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.