Engineering Lead - OSD

Head Engineering

Exp: 15-20 Years

Job Location: Pune

Dept: OSD

Industry: Only pharmaceutical candidates can apply

Role Purpose : Lead Engineering, Utilities, Maintenance, and Capital Projects ensuring compliance with UK MHRA, WHO-GMP, EU- GMP and ENVISA standards while driving operational excellence, reliability, and timely project execution.

Key Responsibilities

• Manage plant engineering, utilities & process maintenance programs to ensure high uptime and reliability.
• Lead brownfield CAPEX projects including planning, budgeting, execution, and timelines.
• Ensure compliance with WHO-GMP, UK MHRA, EU and environmental regulations; support regulatory audits.
• Oversee utilities (HVAC, PW/WFI, electrical, steam, compressed air) and ensure validation (IQ/OQ/PQ).
• Drive safe engineering practices, and sustainability initiatives.
• Promote energy efficiency, renewable solutions, and reduce carbon footprint via waste and emission management.
• Monitor and report sustainability and environmental compliance metrics.
• Lead and develop engineering & project teams; drive continuous improvement.
• Manage vendors, procurement, and optimize engineering/project budgets.

Qualification & Experience

• B.E./B.Tech (Mechanical / Electrical / Instrumentation)
• 16-20 years in pharmaceutical / regulated manufacturing
• Mandatory sterile exposure, including: Prefilled Syringe (PFS) lines, Vial filling lines, In-process engineering in aseptic operations

Key Skills & Competencies

• Strong knowledge of GMP, validation, and regulatory frameworks
• Expertise in HVAC & cleanroom systems
• Strong project management and execution skills
• Leadership and stakeholder management
• Entrepreneurial mindset with ownership
• Ability to manage complexity

KPIs / Success Metrics

• Equipment uptime and reliability
• On-time project delivery within budget
• Audit outcomes (zero critical observations)
• Energy efficiency and cost optimization
• Safety performance (zero incidents)

Reporting Structure

• Reports to: Operations Head
• Leads: Engineering, Maintenance, Projects, Utilities teams