Senior Manager - Process Engineering Maintenance

As a dynamic engineering leader in the Pharmaceutical / Biologics / Injectables industry with 18+ years of experience, you will play a crucial role in overseeing strategic project execution, equipment reliability, and regulatory compliance across manufacturing facilities. Your responsibilities will include: - Leading end-to-end project deliveries including design, installation, commissioning & qualification - Managing engineering operations, maintenance, and utilities (clean & black) - Aligning Capex & Opex budgets with manufacturing goals - Ensuring compliance with FDA, EMA, WHO, MHRA, and other global standards - Driving QMS improvements and documentation (URS, DQ, IQ, OQ) - Implementing cross-contamination control and first-air interruption strategies - Overseeing process maintenance of filling lines (vials, cartridges, PFS), isolators, autoclaves, lyophilizers, and packaging lines (Mikron, Marchesini, Seavision systems) - Maintaining clean utilities such as purified water, WFI, pure steam, AHUs - Leading BMS & EMS implementation projects - Collaborating with vendors and cross-functional teams to drive operational excellence As an additional detail, the company emphasizes the importance of seamless alignment between engineering and manufacturing operations, driving continuous improvement, and maintaining audit readiness to ensure the highest standards of quality and compliance.,