Senior Manager

4 weeks ago


bangalore, India Biocon Biologics Full time

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



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