Manager/Sr. Manager - Engineering -Drug Product (Injectable)

Role & responsibilities Key Responsibilities Lead Engineering & Utilities for sterile injectable formulation and filling operations. Manage cleanroom facility, equipment & utility design, qualification, and lifecycle management. Oversee Black & clean utilities WFI, Purified Water, Clean Steam, Compressed Air, HVAC, AHU, HEPA, LAF/RABS/Isolators. Implement robust preventive, predictive & breakdown maintenance programs. Ensure process automation SCADA, PLC, BMS, MES, and digital monitoring systems. Preparation & managing of CAPEX & OPEX for Engineering Section. Lead equipment qualification & process validation (IQ/OQ/PQ) and documentation. Maintain regulatory compliance USFDA, EMA, MHRA, WHO, PIC/S, etc. Ensure audit readiness – support inspections, manage observations & CAPA closures/compliance. Manage QMS documentation – change controls, deviations, CAPA. Collaborate cross-functionally with QA, Production, EHS, Regulatory, R&D teams. Hands on experience in SAP. Ensure sterility assurance & contamination control strategy compliance. Lead safety & EHS programs – incident prevention, risk assessments (HAZOP, FMEA). Drive continuous improvement initiatives – Lean, TPM, Kaizen, 5S. Build, coach & lead a high-performing engineering team; define training & succession plans. Manage vendor development & contractor performance – ensure GMP & safety compliance. Reduce equipment downtime, optimize OEE, and improve plant reliability. Ensure zero critical observations during audits related to engineering activities. Preferred candidate profile Sterile/Injectable facility operations & maintenance Clean utilities (WFI/PW/Clean Steam/Compressed Air) Equipment qualification, validation & documentation Process automation (SCADA, PLC, BMS, MES) Regulatory compliance (USFDA, EMA, WHO, PIC/S) CAPEX/OPEX project planning & execution QMS, SOP & change control management Audit readiness & inspection handling Team leadership & cross-functional collaboration Safety & EHS compliance Continuous improvement (Lean, TPM, 5S)