- Lead and Manage Instrumentation section at Enzene Biosciences.

- Define and implement Instrumentation strategies including roadmaps, tools, and approaches across the organization.

- Participate in design and architectural reviews of proposed Instrumentation solutions across R&D; and Manufacturing project teams.

- Should have good understanding of SOPs preparation, change management, Deviation, QRM and other QMS related to engineering.

- Should have personally faced major regulatory audits like USFDA, EMA, TGA, ANVISA, PMDA, etc.

- Should have good understanding of Plant Automation, Calibrations, process manufacturing, Quality Systems, and regulatory workplace.

- Prepare, Execute, document the annual calibration planner. Lead or support the vendor activities of external vendors for Calibration. Keep calibration reports & certificates updated.





- Collaborate with key stakeholders and get clearance for instrument availability for calibration.

- Willing to work in extended hours as and when required.

- Develop business processes, guidelines, and training for the MES system.

- Mange and involve into on going capital projects and modification related to Automation & Instrumentation in Engineering.

- Should have good exposure and responsible manager for regulatory and customer audit. Should be able to face regulatory audits as Calibration SME.

- Should be able to draft and finalize audit observation response related to calibration & Instrumentation.

- Supporting to Unit-2 & R&D; for anything related to Project execution and Breakdowns on need base.

📌 Assistant Manager (Pune)
🏢 Enzene Biosciences
📍 Pune