Job Title: Executive / Senior Executive Engineering (Utilities) Department: Engineering & Maintenance / Technical Service Experience: 7 to 10 years in Sterile/Injectable pharmaceutical manufacturing Education: B.E. / B.Tech in Mechanical, Chemical, or Electrical Engineering Location : Vadodara
Core Responsibilities
1. Qualification & Validation (Commissioning Phase) Protocol Execution: Draft, review, and execute Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for HVAC and Water systems.
Cleanroom Qualification: Lead smoke studies (airflow visualization), HEPA filter integrity testing (PAO/DOP), air change rate calculations, and pressure cascade balancing.
Water Loop Validation: Manage Phase I, II, and III validation protocols for the Water for Injection (WFI) loop, Purified Water (PW) system, and Pure Steam Generators (PSG).
Vendor Management: Coordinate with Original Equipment Manufacturers (OEMs) and third-party validation agencies to ensure compliance with project timelines.
2. Routine Operations & Maintenance System Monitoring: Ensure 24/7 uninterrupted operation of the generation and distribution loops for WFI, PW, and Pure Steam.
HVAC Control: Oversee Building Management Systems (BMS/EMS) to monitor temperature, relative humidity (RH), and differential pressures across Grades A, B, C, and D cleanrooms.
Preventive Maintenance:



Design and execute the Annual Preventive Maintenance (PM) schedules for chillers, Air Handling Units (AHUs), multi-column distillation plants, and storage tanks.
Breakdown Resolution: Lead troubleshooting efforts during utility breakdowns to minimize production downtime while maintaining sterile integrity.
3. Compliance, Documentation & Quality Assurance Logbook Maintenance: Maintain online, error-free documentation, including equipment logs, PM checklists, and operational shift reports.
Data Integrity: Ensure all electronic records and data from automated systems (BMS, PLC) strictly adhere to 21 CFR Part 11 guidelines.
Quality Metrics: Raise, investigate, and close Deviations, Change Controls, and Corrective and Preventive Actions (CAPAs) related to engineering utilities.
Audit Readiness: Act as the subject matter expert (SME) for Water and HVAC systems during regulatory audits (USFDA, MHRA, CDSCO).
Interested candidates may drop their updated resumes or apply on [email protected] or call on (phone hidden) with following mentioned details:

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Mahesh Vankar Hr Recruiter

📌 Executive / Sr. Executive Enginering (Utilities) (Por)
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