Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industriesPQE 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 oversight with a strong experience within pharmaceutical, medical device or life sciences manufacturing, to support our projects in 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.
- 7+ 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).
Next steps
Upon receiving your application, if a match is found, the Talent Acquisition department will contact you for an initial HR interview. If there is a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback is negative, we will contact you to halt the recruitment process.
Working at PQE Group
As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.
