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Engineering Manager

Engineering Manager

Endo

0 years

0 Lacs

Indore Madhya Pradesh India

Posted:8 hours ago| Platform:

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Skills Required

engineering design compliance maintenance analysis documentation audit optimization technology calibration controls reports sap

Work Mode

On-site

Job Type

Full Time

Job Description

Sound knowledge on Handling of HVAC and utilities related to injectable .

HVAC Systems Management:

Design, implement, and maintain HVAC systems to meet cleanroom classifications (ISO 5–8) and regulatory requirements (USFDA, EU-GMP, WHO-GMP).

Utilities Oversight:

Manage critical utilities including WFI, RODI, Pure Steam, Compressed Air, Nitrogen, and chilled water systems. Ensure continuous availability and compliance with pharmacopeial standards.

Preventive & Breakdown Maintenance:

Develop and execute preventive maintenance schedules. Lead root cause analysis and corrective actions for equipment failures.

Regulatory Compliance:

Ensure all systems and documentation comply with cGMP, GEP, and audit requirements. Participate in regulatory inspections and internal audits.

Project Management:

Lead utility and HVAC-related projects including capacity expansion, energy optimization, and technology upgrades.

Team Leadership:

Supervise and mentor a team of engineers and technicians. Foster a culture of safety, quality, and continuous improvement.

Documentation & QMS:

Maintain SOPs, calibration records, change controls, and deviation reports. Work within QMS platforms like Track wise or SAP.

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Engineering Manager