Job Description

To execute engineering projects related to facility upgrades, equipment installation, and compliance enhancements in alignment with cGMP and USFDA standards.
Key Responsibilities:
Project Execution & Management:

• Assist in planning, scheduling, and executing engineering projects including new installations, modifications, and expansions.
• Coordinate with cross-functional teams (Production, QA, QC, EHS) for smooth execution.
• Ensure timely completion of projects within budget and quality parameters.

Compliance & Documentation:

• Ensure all engineering activities comply with USFDA, cGMP, and other regulatory requirements.
• Prepare and maintain project documentation including URS, DQ, IQ, OQ, PQ, and change control records.
• Support in audits and inspections by regulatory bodies.

Vendor & Contractor Coordination:

• Liaise with vendors and contractors for equipment procurement, installation, and commissioning.
• Review technical specifications and validate vendor deliverables.

Safety & Quality:

• Ensure adherence to safety protocols during project execution.
• Conduct risk assessments and implement mitigation plans.

Continuous Improvement:

• Identify opportunities for process and infrastructure improvements.
• Support energy conservation and sustainability initiatives.

Qualifications & Experience:

• Education: B.E./B.Tech in Mechanical / Electrical / Instrumentation / Chemical Engineering
• Experience: 8-12 years in engineering projects within a regulated pharmaceutical environment (preferably USFDA-approved facility)
• Skills:

• Knowledge of HVAC, cleanroom design, utility systems, and pharma-grade equipment
• Familiarity with AutoCAD, MS Project, and engineering documentation
• Strong understanding of cGMP, USFDA, and other regulatory guidelines

Key Competencies:

• Project management
• Technical problem-solving
• Communication and coordination
• Regulatory compliance awareness
• Time and resource management

Skills Required