Engineer - Utility

This role is responsible for ensuring the reliable, safe, and compliant operation of all critical water systems including WFI, Purified Water, and related utilities, through systematic monitoring, preventive maintenance, and strict adherence to GMP, quality, and regulatory requirements.

Responsibilities:

• Ensure smooth operation & preventive maintenance of WFI, purified water, PSG, HSRO & CSRO systems.
• Monitor system parameters, conduct routine checks & maintain logbooks
• Liaise with equipment vendors for AMC, servicing & upgrades.
• Ensure the smooth operation & calibration is conducting as per the SOP/ EOP.
• Ensure adherence to SOPs & regulatory requirements (FDA, UE, WHO)
• Maintain GMP - compliant records (logbooks, calibration, maintenance)
• Handle change controls, deviations, CAPA & Risk assessments related to water systems
• Participate in internal & external audits & ensure timely closure of observations
• Handle change controls, deviations, CAPA & risk assessments
• Participate in equipment qualification (IQ/ OQ/ PQ)
• Support requalification & validation activities
• Conduct sampling & testing coordination for microbial & chemical parameters
• Follow EHS guidelines & ensure safe operations
• Train junior staff on system handling & GMP documentation

Education Qualification & Experience:

• BE/ Btech – Mechanical / Electrical
• 3 - 6 years of experience in pharmaceutical (Sterile)/ medical device industry only

Essential area of knowledge:

• Must have knowledge and experience in Operation, trouble shooting & preventive maintenance & sanitization/ sterilization of pre & post treatment of water systems (WFI, PW, HSRO, PSG, CSRO, generation & distribution system.