Senior CSV & Automation Engineer

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.

Due to our constant growth, we are looking for a Senior CSV & Automation Engineer to support our projects in Singapore.

The ideal candidate bridges the gap between Industrial Automation and Computer System Validation (CSV). You will play a key role in managing the validation lifecycle of automated computerized systems, ensuring strict adherence to GAMP5, Data Integrity (ALCOA+), and regulatory compliance (21 CFR Part 11) within GxP-regulated manufacturing environments.

Key Responsibilities:

• System Categorization & Risk Assessment: Define GxP vs. Non-GxP impact, determine system criticality, and assign GAMP5 categories for new and existing computerized systems.
• Validation Lifecycle Management: Draft, review, and execute full CSV lifecycle documentation - including URS, Functional/Design Specifications, Risk Assessments (FMEA), Traceability Matrices, and IQ/OQ/PQ protocols.
• Periodic System Reviews (PSR): Establish review frequencies, execute periodic reviews, and perform ongoing compliance/gap assessments for automation and SCADA systems.
• Data Integrity & Regulatory Compliance: Ensure all automated systems align with 21 CFR Part 11, EU Annex 11, and ALCOA+ principles, including Audit Trail reviews and User Access Management.
• Automation & Infrastructure Oversight: Provide compliance oversight for industrial control systems (Siemens, Rockwell PLCs/SCADA) and virtualized environments (VMware/Hyper-V) hosting automation software.
• Change Control & Deviations: Manage Change Controls, software updates, and deviation investigations for operational automation systems following strict site quality procedures.

About You:

• Experience: 5+ years of experience in Computer System Validation (CSV) and Quality Compliance within a regulated Pharmaceutical or Biotech environment.
• CSV Expertise: Strong, demonstrable knowledge of the full CSV lifecycle, GAMP5 guidelines, GxP impact assessments, Data Integrity standards, and 21 CFR Part 11 / EU Annex 11.
• Technical Background: Solid understanding of industrial automation architectures (Siemens TIA Portal, Rockwell Studio 5000, SCADA/HMIs) and basic virtualized infrastructure (VMs) to effectively validate technical systems.
• Documentation Skills: Proven ability to independently write, execute, and defend robust validation documentation during audits or quality reviews.
• Education: Bachelor's Degree in Automation, Electrical Engineering, Computer Science, Biotechnology, or a related technical discipline.

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there's a positive match, a technical interview with the Hiring Manager will be arranged.

In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.

Alternatively, if the outcome 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