Associate Director - Engineering
Endo
Date: 2 weeks ago
City: Indore, Madhya Pradesh
Contract type: Full time
Job Description Summary
Handling of utilities of injectable including regulatory and statutory compliance knowledge facility management .
Job Description
Handling of utilities of injectable including regulatory and statutory compliance knowledge facility management .
Job Description
- Project Leadership:
- Lead end-to-end execution of greenfield/brownfield injectable facility projects, including design, budgeting, procurement, construction, commissioning, and qualification.
- Utilities Oversight:
- Ensure uninterrupted and compliant operation of critical utilities—WFI, Pure Steam, RODI, HVAC, Compressed Air, Nitrogen, and chilled water systems.
- Regulatory Compliance:
- Ensure all systems and documentation meet cGMP, GEP, and regulatory standards (USFDA, EU-GMP, WHO-GMP). Prepare for and support audits and inspections.
- Cross-Functional Collaboration:
- Work closely with QA, Production, Validation, and EHS teams to align project deliverables with operational and compliance needs.
- Vendor & Contractor Management:Evaluate and manage third-party vendors, consultants, and contractors to ensure timely and quality project execution.
- Sustainability & Energy Efficiency:
- Drive initiatives for energy optimization, water conservation, and sustainable engineering practices.
- Team Development:
- Mentor and lead a team of project engineers and utility specialists. Foster a culture of accountability, safety, and continuous improvement.
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