CQV Engineer – SIP PQ Support

Advanced Manufacturing Tech Solutions (AMTSOL)

Job Location:

Singapore - Singapore

Monthly Salary: Not Disclosed

Posted on: 5 hours ago

Vacancies: 1 Vacancy

Job Summary

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: 58 Years
Location: Site-based

Role Overview

We are seeking an experienced CQV Engineer with 58 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

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.
58 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.

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: 58 Years Location: Site-base...