Senior Process Engineering Leader

Industry : Pharmaceutical / Biologics / Injectables

Experience : 18+ years

About the Role

We are seeking a dynamic engineering leader to oversee strategic project execution, equipment reliability, and regulatory compliance across injectable and biologics manufacturing facilities. This role plays a pivotal part in ensuring seamless alignment between engineering and manufacturing operations while driving continuous improvement and audit readiness .

Key Responsibilities

• Lead end-to-end project deliveries – design, installation, commissioning & qualification
• Manage engineering operations, maintenance, and utilities (clean & black)
• Align Capex & Opex budgets with manufacturing goals
• Ensure compliance with FDA, EMA, WHO, MHRA, and other global standards
• Drive QMS improvements and documentation (URS, DQ, IQ, OQ)
• Implement cross-contamination control and first-air interruption strategies
• Oversee process maintenance of :
• Filling lines (vials, cartridges, PFS)
• Isolators
• Autoclaves
• Lyophilizers
• Packaging lines (Mikron, Marchesini, Seavision systems)
• Maintain clean utilities – purified water, WFI, pure steam, AHUs
• Lead BMS & EMS implementation projects
• Collaborate with vendors and cross-functional teams to drive operational excellence