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 EngineeringExperience : 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 equipmentFamiliarity with AutoCAD, MS Project, and engineering documentationStrong understanding of cGMP, USFDA, and other regulatory guidelinesKey Competencies :
Project managementTechnical problem-solvingCommunication and coordinationRegulatory compliance awarenessTime and resource managementSkills Required
Usfda, Ms Project, Cgmp, Autocad, utility systems , engineering documentation