Lead CSV Engineer (Computer SystemValidation)

Company Description :

Virtual Manufacturing (Thailand) CO., Ltd. is part of the Virtual Manufacturing group, headquartered in Sweden. We are a Tulip partner andrun manufacturing and life-science projects for global clients. Our engineers work remotely across Thailand and at client sites in theregion.

Lead validation on our electronic device history record (eDHR) and MES projects on the Tulip platform, for medical-device andpharma clients. You report to our Head of Life Science, set the validation approach for your projects, guide our CSV engineers andrepresent validation in front of client Quality and audit teams.

Role Description :

• Own the validation approach for your projects, from theValidation Master Plan to release, under GAMP 5, 21 CFRPart 11 and EU Annex 11
• Write, review and approve the VMP, URS, risk assessments,specifi cations, IQ/OQ/PQ protocols and reports,traceability matrix and summary report
• Decide risk-based test scope, deviations and acceptancecriteria, and defend them to client Quality
• Guide our CSV engineers: assign and review their work, andbuild their skills in GAMP 5 and data integrity
• Represent validation in client meetings, audits andinspections; plan eff ort and timelines with the projectmanager
• Build our CSV templates and standards for Tulip projects,and train project and client teams

Qualifications :

MUST HAVE

• 7 or more years of computer system validation in pharma,biotech or medical-device manufacturing
• At least 2 years as validation lead on a project, or leadingvalidation engineers
• MES, LIMS or eDHR validation from planning to release,including work you defended in a client or regulatory audit
• GxP, Part 11, Annex 11, GAMP 5 and data integrity(ALCOA+) applied in real projects
• Fluent English, written and spoken

NICE TO HAVE

• Tulip, or another low-code platform such as Power Apps
• eDHR in an FDA-regulated plant; Computer SoftwareAssurance (CSA)
• Building a validation framework from the ground up
• Thai English is our working language. Thai is a plus.

Why join us :

• Lead validation on live digital manufacturing programmes in regulated plants
• Shape how we validate Tulip solutions across the region
• Small team with short lines to clients and to the people who build the system

LOCATION :

Remote, based in Thailand, with work at client sites in the region

Benefits:

Social security, Group insurance, Provident Fund, Healthly Lifestyle allowance.