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Assistant Manager, Mechanical Engineering at Amneal India
, gujarat, India -
Full Time

Start Date

Immediate

Expiry Date

16 Jun, 26

Salary

0.0

Posted On

18 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

HVAC Systems, cGMP, FDA Norms, Project Management, Vendor Management, FAT/SAT, Qualification Protocols, BMS, Cleanroom Design, AutoCAD, MS Project, Primavera, Utility Design, Cross-functional Coordination, Negotiation, Problem-Solving

Industry

Pharmaceutical Manufacturing

Description
Plan, coordinate and execute mechanical engineering activities for projects (greenfield/brownfield)  Review BOQs, layouts, specifications and ensure installation of HVAC, utilities and cleanroom systems as per cGMP & FDA norms.  Collaborate with cross-functional teams – QA, QC, Production, EHS, Maintenance – for seamless project execution and compliance.  Monitor project schedules (MS Project), milestones and critical path to ensure on-time delivery.  Lead vendor management, contractor supervision and technical review meetings for mechanical systems.  Conduct equipment FAT/SAT, qualification protocols (DQ, IQ, OQ) and manage mechanical documentation for regulatory audits.  Ensure adherence to safety, quality and statutory norms across all stages of mechanical work.  Strong knowledge of HVAC systems, AHUs, Chillers, Compressors, Boilers, BMS, and cleanroom design.  Familiar with IS, ASME, and cGMP engineering standards.  Proficient in AutoCAD, MS Project/Primavera, and utility design tools.  Knowledge of WFI, PW, steam and compressed air generation/distribution systems.  Strong cross-functional coordination and leadership.  High accountability and ownership of timelines.  Detail-oriented, quality-driven, and safety-conscious.  Excellent communication, negotiation, and documentation skills.  Problem-solving mindset with agility to adapt to changes.
Responsibilities
The role involves planning, coordinating, and executing mechanical engineering activities for projects, including reviewing specifications and ensuring the installation of HVAC, utilities, and cleanroom systems adhere to cGMP and FDA norms. This includes leading vendor management, monitoring project schedules, and conducting equipment qualification protocols.