Site Engineering Head

Position Title: Site Head Engineering
Department: Engineering & Maintenance
Location: Padra, Vadodara

Position Summary:

The Site Head – Engineering (GM/Sr. GM Level) will be responsible for overseeing and managing the entire engineering and maintenance functions for both Pharma (Formulations) and Lifesciences (API) operations at the Padra, Vadodara site. The role demands a strategic leader with regulated market exposure, extensive experience in handling USFDA audits, and expertise in engineering operations, containment systems, and facility maintenance. The ideal candidate must have hands-on experience handling cytotoxic product equipment, isolators, HVAC systems with BIBO (Bag-In Bag-Out), wet scrubbers, OEL (Occupational Exposure Limit) studies, containment design, and maintenance to ensure compliance with stringent regulatory requirements.

Key Responsibilities:

Engineering & Maintenance Leadership:

• Lead the overall engineering function for Formulations and API operations, ensuring smooth plant operations and regulatory compliance.
• Develop and implement engineering strategies to optimize production efficiency, minimize downtime, and ensure cost-effective maintenance.
• Drive the preventive and predictive maintenance programs for all critical equipment and utilities.

Regulatory Compliance & Audit Readiness:

• Ensure the engineering function complies with USFDA, EU GMP, MHRA, and other global regulatory standards.
• Play a key role in handling USFDA and other regulatory audits as the Engineering Head, ensuring all compliance requirements are met.
• Maintain audit readiness by implementing best practices in equipment qualification, validation, and documentation.
• Ensure that containment systems and OEL study protocols are in compliance with regulatory and safety standards.

Project Management & Facility Upgradation:

• Lead expansion, upgradation, and modernization projects for both formulation and API facilities, with a focus on cytotoxic manufacturing and containment technology.
• Oversee capital expenditure (CAPEX) projects, ensuring timely completion within budget.
• Implement energy efficiency and sustainability initiatives to optimize operational costs.
• Supervise containment design, isolators, and wet scrubber systems to ensure compliance with occupational exposure guidelines.

Utilities & Equipment Management:

• Manage and maintain critical utilities such as HVAC with BIBO (Bag-In Bag-Out) systems, purified water systems, compressed air, and effluent treatment plants.
• Ensure the availability and optimal performance of manufacturing equipment, clean rooms, reactors, packaging lines, and cytotoxic handling systems for both formulations and API production.
• Implement automation and digitization in engineering processes for better efficiency, compliance, and data tracking.
• Conduct OEL studies and monitor exposure control measures to ensure workplace safety and regulatory adherence.

Safety, Environment & Compliance:

• Ensure adherence to HSE (Health, Safety & Environment) policies and drive a culture of safety in all engineering operations.
• Monitor environmental compliance, including effluent treatment, hazardous waste management, and containment system validations as per local and international guidelines.
• Ensure all containment design and maintenance protocols adhere to industry best practices to minimize occupational exposure risks.

Team Leadership & Development:

• Build and lead a high-performing engineering team, ensuring continuous skill development and performance management.
• Foster a culture of innovation, accountability, and operational excellence within the engineering function.
• Train teams on cytotoxic product handling, isolator maintenance, and containment best practices to enhance technical expertise.

Qualifications and Experience:

Education:

• B.E. / B.Tech in Mechanical, Electrical, Chemical, or Industrial Engineering.
• A Master’s degree or certifications in Engineering Management, Industrial Automation, or GMP Compliance will be an added advantage.

Experience:

• Minimum 15+ years of experience in the pharmaceutical industry, specifically in Formulations & API manufacturing facilities.
• Must have experience handling USFDA, EU GMP, and other international regulatory audits as the Engineering Head.
• Strong experience in managing engineering operations, plant maintenance, capital projects, and containment systems.

Specialized Skills & Competencies:

• Regulatory Knowledge: Strong understanding of USFDA, EU GMP, and regulatory compliance in engineering functions.
• Containment Technology Expertise: Experience in handling cytotoxic product equipment, isolators, HVAC with BIBO, wet scrubbers, and OEL studies.
• Project Management: Hands-on experience in leading expansion and upgradation projects, including containment system installations.
• Leadership & Team Management: Proven ability to lead, mentor, and develop high-performing engineering teams.
• Problem-Solving & Innovation: Ability to drive continuous improvement and adopt new technologies for enhanced efficiency.

Key Performance Indicators (KPIs):

• Audit Readiness & Compliance: Zero critical observations in regulatory audits.
• Operational Efficiency: Reduction in downtime and improvement in overall equipment efficiency (OEE).
• Project Execution: Timely completion of CAPEX projects within budget.
• Energy & Cost Optimization: Implementation of cost-saving and energy-efficient initiatives.
• Safety & Environmental Compliance: Adherence to HSE standards with zero safety incidents.
• Containment System Effectiveness: Compliance with OEL limits and optimal performance of BIBO, isolators, and wet scrubbers.