Amneal Pharmaceuticals

Senior Manager, Process Engineering

Amneal Pharmaceuticals Ahmedabad, Gujarat, India

Job Description

Key Responsibilities: 1. Engineering Operations & Maintenance:

  • Oversee the maintenance of plant equipment, utilities, and facilities to ensure smooth manufacturing operations.
  • Ensure optimal functioning of HVAC, WFI, purified water, and cleanroom environments in compliance with regulatory guidelines.
  • Implement predictive, preventive, and corrective maintenance strategies.

2. Project Management & Expansion:

  • Lead capital projects, including facility expansions, equipment installation, and process automation.
  • Ensure projects are completed on time, within budget, and meet compliance standards.
  • Collaborate with cross-functional teams for successful project execution.

3. Compliance & Regulatory Adherence:

  • Ensure adherence to USFDA, MHRA, EU GMP, WHO, and other regulatory requirements.
  • Lead audits and inspections by regulatory agencies and customers.
  • Maintain engineering documentation, validation protocols, and risk assessments.

4. Automation & Technology Upgradation:

  • Drive automation initiatives for efficiency, cost optimization, and compliance improvement.
  • Implement Industry 4.0 technologies, including IoT, SCADA, and MES.
  • Evaluate and adopt new engineering technologies for injectable manufacturing.

5. Energy & Cost Optimization:

  • Develop and implement strategies for energy conservation and operational cost reduction.
  • Optimize utility consumption, waste management, and sustainability initiatives.

6. Team Leadership & Development:

  • Lead, mentor, and develop the engineering team.
  • Ensure training programs for technical competency and regulatory compliance.
  • Promote a culture of continuous improvement and operational excellence.

Qualifications

Qualifications & Experience:

  • Education: B.E./B.Tech/M.E./M.Tech in Mechanical, Electrical, or Chemical Engineering.
  • Experience: 15+ years in engineering leadership roles in injectable pharmaceutical manufacturing.
  • Proven expertise in regulatory compliance, equipment qualification, and plant engineering.
  • Experience in project management, automation, and operational excellence.
  • Strong knowledge of regulatory guidelines (USFDA, EU GMP, MHRA, WHO).

Key Skills:

  • Engineering Operations & Maintenance
  • Project Management & Execution
  • Regulatory Compliance & Audit Handling
  • Automation & Industry 4.0 Implementation
  • Energy Management & Cost Optimization
  • Leadership & Team Development
  • Seniority level

    Director
  • Employment type

    Full-time
  • Job function

    Engineering and Information Technology
  • Industries

    Pharmaceutical Manufacturing

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