Title:  Executive - Engineering Projects

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