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

Saf

📌 Manager/Sr. Manager (Pune)
🏢 MJ Biopharm
📍 Pune