CQV Engineer – SIP PQ Support

AMTSOL - A Leader in Life science Manufacturing Technology solutions, we are looking for top talent to be part of the dynamic team and drive the growth of the business. Job Title: CQV Engineer – SIP PQ Support Industry: Pharmaceutical / Biotech / Life Sciences Experience: 5–8 Years Location: Site-based Role Overview We are seeking an experienced CQV Engineer with 5–8 years of hands-on experience to support Steam-In-Place (SIP) Performance Qualification (PQ) activities within GMP pharmaceutical manufacturing environments. The role is focused on execution-driven support during SIP PQ campaigns, working closely with Site Engineering, Manufacturing, and Quality teams to ensure compliant and timely qualification of process equipment and utilities. Key Responsibilities Develop/Execute SIP Performance Qualification (PQ) activities in line with approved protocols and site standards. Support on-site execution of SIP cycles, including monitoring, data collection, and verification of critical parameters (temperature, pressure, time). Review and verify SIP data, trends, and acceptance criteria to support PQ completion. Coordinate closely with Manufacturing, Utilities, Automation, and QA during PQ execution windows. Support deviation handling, investigations, and CAPA actions arising from SIP PQ execution. Assist in preparation and review of PQ summary reports and execution records. Ensure compliance with GMP, EU Annex 1, and site CQV standards. Provide real-time troubleshooting and execution support during qualification campaigns. Required Qualifications & Experience Bachelors degree in Engineering or a related technical discipline. 5–8 years of CQV experience in GMP-regulated pharmaceutical or biotech facilities. Strong hands-on experience executing SIP PQ for process equipment and/or utilities. Solid understanding of sterilization principles, critical parameters, and acceptance criteria for SIP systems. Experience working in live manufacturing / brownfield environments. Familiarity with GMP documentation practices, deviations, and change control processes. Ability to work independently during intensive PQ execution phases. Nice to Have Experience with CIP/SIP systems, autoclaves, or clean utilities (WFI, Clean Steam). Prior exposure to aseptic manufacturing or sterile product facilities. Experience supporting regulatory inspections or audit readiness during qualification phases.