Senior Manager

2 weeks ago


bangalore, India Biocon Biologics Full time

Industry: Pharmaceutical / Biologics / InjectablesExperience: 18+ yearsAbout the RoleWe 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 ResponsibilitiesLead end-to-end project deliveries – design, installation, commissioning & qualificationManage engineering operations, maintenance, and utilities (clean & black)Align Capex & Opex budgets with manufacturing goalsEnsure compliance with FDA, EMA, WHO, MHRA, and other global standardsDrive QMS improvements and documentation (URS, DQ, IQ, OQ)Implement cross-contamination control and first-air interruption strategiesOversee 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, AHUsLead BMS & EMS implementation projectsCollaborate with vendors and cross-functional teams to drive operational excellence



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