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.