Senior Manager, Process Engineering

Amneal Pharmaceuticals • Full-time • Ahmedabad, IN • 3w ago

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:

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: