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Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

General Manager – Engineering

Job Description

JOB OVERVIEW:

Head of Engineering & Maintenance- will lead all engineering and maintenance operations for a large-scale API pharmaceutical plant. This role is responsible for ensuring the optimal performance, reliability, and compliance of plant equipment, systems, and facilities. The position requires extensive experience in API manufacturing, including expertise in CGMP, FDA regulations, and managing regulatory audits. Develop and execute maintenance strategies, drive continuous improvement, manage OPEX budgets, and lead a high-performing team to ensure safe, efficient, and compliant plant operations.

KEY STAKEHOLDERS: INTERNAL

Production , Supply Chain, Finance, Warehouse, operation excellence ,HR/QA, QC & Validation.

KEY STAKEHOLDERS: EXTERNAL

Govt Departments, Regulatory Agencies, Suppliers, Vendors

REPORTING STRUCTURE: Reports to Global Engineering & Project head & Site head , Direct reportees all plant engineering & maintenance team

ESSENTIAL QUALIFICATION: Bachelor’s degree in Engineering (Mechanical, Electrical, or related field)

RELEVANT EXPERIENCE: > 20 years in a Pharmaceutical API Facility

Qualification : B.Tech (Mechanical)

Experience: 20 Years +

KEY ROLES/RESPONSIBILITIES:

Leadership & Strategy:

• Lead, manage, and develop the Engineering & Maintenance team to drive plant operational excellence.
• Develop and execute a comprehensive maintenance strategy, ensuring a proactive approach to maintenance, asset integrity, and equipment reliability.
• Drive continuous improvement initiatives to optimize plant performance and reduce unplanned downtime.
• Manage operating expenditure (OPEX) budgets for Engineering & Maintenance activities.

Maintenance & Reliability Management:

• Ensure all critical equipment and systems are maintained in optimal condition to meet production goals and regulatory requirements.
• Oversee the implementation of preventive and predictive maintenance programs, improving plant uptime and reliability.
• Develop and implement a comprehensive asset management strategy, including lifecycle management for critical equipment.

Regulatory Compliance & Safety:

• Ensure all maintenance activities are compliant with GMP, FDA, and other relevant pharmaceutical regulations.
• Promote a culture of safety and adherence to the highest environmental, health, and safety (EHS) standards.
• Lead the investigation and resolution of any maintenance-related incidents, ensuring timely and effective corrective actions.

Team Development & Talent Management:

• Mentor, train, and develop Engineering & Maintenance personnel, ensuring their skills and capabilities meet the evolving needs of the plant.
• Foster a culture of collaboration, teamwork, and continuous learning within the team.
• Lead recruitment efforts to fill skill gaps within the department and drive talent development initiatives.

Collaboration & Cross-Functional Coordination:

• Work closely with Production, Quality, and Supply Chain departments to ensure alignment between maintenance schedules and production plans.
• Collaborate with the plant leadership team to identify opportunities for process optimization, cost reductions, and productivity improvements.

Technology & Innovation:

• Identify and implement new technologies that improve equipment performance, reduce maintenance costs, and enhance production efficiency.
• Stay current with industry best practices, technology advancements, and emerging trends in pharmaceutical manufacturing and maintenance

KEY COMPETENCIES:

Must have extensive experience in API pharmaceutical manufacturing, with a deep understanding of CGMP, FDA regulations, and other regulatory audit requirements. Expertise in ensuring compliance with these standards while optimizing maintenance strategies and driving operational improvements is essential. The role requires a strong track record in managing audits, addressing non-conformities, and maintaining a high standard of product quality and safety.

Bachelor of Engineering (BE)