Assistant Manager, Mechanical Engineering

Amneal Pharmaceuticals is seeking a highly skilled and proactive Assistant Manager – Mechanical Engineering to lead and execute mechanical engineering projects across greenfield and brownfield facilities while ensuring compliance with cGMP, FDA, and engineering standards. The involves planning, coordination, and execution of HVAC, utility, and cleanroom systems, along with cross-functional collaboration to ensure timely and compliant project delivery.

Roles & Responsibilities

• Plan, coordinate, and execute mechanical engineering activities for greenfield and brownfield projects.
• Review BOQs, engineering layouts, and technical specifications for mechanical systems.
• Ensure installation and commissioning of HVAC, cleanroom, and utility systems as per cGMP and FDA norms.
• Oversee systems such as AHUs, chillers, compressors, boilers, and building management systems (BMS).
• Monitor and manage project schedules, milestones, and critical paths using tools like MS Project or Primavera.
• Ensure timely completion of projects byentifying and resolving execution challenges.
• Collaborate with QA, QC, Production, EHS, and Maintenance teams for seamless execution and compliance.
• Lead vendor management, contractor supervision, and technical review meetings.
• Evaluate vendor performance and ensure quality and cost-effective project execution.
• Conduct FAT (Factory Acceptance Test) and SAT (Site Acceptance Test) for mechanical equipment.
• Support and execute qualification activities including DQ, IQ, and OQ protocols.
• Maintain and manage mechanical documentation required for audits and regulatory inspections.
• Ensure compliance with IS, ASME, cGMP, and other applicable engineering standards.
• Ensure adherence to safety, quality, and statutory requirements across all project phases.
• Design and optimize utility systems including WFI, purified water (PW), steam, and compressed air systems.
• Utilize AutoCAD and other engineering tools for design review and system planning.
• Perform risk assessments and implement mitigation strategies for mechanical systems.
• Provide technical guidance and support to internal teams and stakeholders.
• Maintain strong coordination and communication across cross-functional teams.
• Ensure high accountability for timelines, quality, and project deliverables.
• Maintain detailed and accurate documentation for all engineering activities.
• Drive continuous improvement in mechanical systems and project execution practices.
• Demonstrate strong problem-solving skills and adaptability to changing project requirements.
• Support audits, inspections, and validation activities with required technical inputs.