Total 1 job vacancies by Pqe Singapore Pte. Ltd.

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

Following a new opportunity, we are currently looking for a Senior CSV Engineer (QA and Validation) with a strong experience in Computer System Validation within pharmaceutical, medical device or life sciences manufacturing, to support our projects in Tuas/Pioneer, Singapore. 

You'll Be Responsible For: 

• Leading the Computer System Validation (CSV) lifecycle activities for DCS (e.g., DeltaV, Honeywell Experion) and MES platforms (e.g., PAS-X, Syncade).
• Providing onsite QA oversight and support during IQ/OQ/PQ execution, ensuring compliance with validation protocols and procedures.
• Collaborating with Engineering and Automation teams to align validation deliverables with the Master Validation Plan (MVP).
• Conducting Data Integrity assessments in line with ALCOA+ principles and ensuring system compliance with regulatory expectations.
• Reviewing and approving system configurations, including audit trails, access controls, backup procedures, and data security measures.
• Managing QA deviations, non-conformances, and CAPA activities related to validation testing.
• Supporting regulatory inspections and internal audits as the CSV Subject Matter Expert (SME).
• Maintaining validation documentation in an inspection-ready state at all times.
• Overseeing Change Control activities related to software and hardware updates to ensure systems remain in a validated state.
• Ensuring adherence to GAMP 5, PIC/S, FDA 21 CFR Part 11, and applicable regulatory requirements. 

About You: 

• Bachelor’s degree in Engineering (Chemical, Electrical, Mechanical, Biomedical, or Automation), Computer Science/IT, Life Sciences, or Quality Management.
• 8+ years of experience in Computer System Validation (CSV) or Quality Assurance within a GMP-regulated environment.
• Proven experience supporting validation of DCS and MES systems within pharmaceutical, biotechnology, or life sciences manufacturing environments.
• Strong understanding of GAMP 5, PIC/S, and regulatory data integrity requirements (including ALCOA+ principles).
• Hands-on experience with validation lifecycle documentation, including URS, FS, DS, IQ, OQ, and PQ.
• Familiarity with SQL databases, industrial networks, and PLC-based systems is highly desirable.
• Experience supporting regulatory inspections and maintaining audit readiness.
• Strong communication and stakeholder management skills, with the ability to work cross-functionally in a complex manufacturing environment.

 Nice to Have: 

• Prior experience working on large-scale automation or digital manufacturing projects.
• Experience in regulated life sciences manufacturing environments such as pharmaceuticals or biologics.
• Exposure to global regulatory inspections (e.g., FDA or regional authorities).