GxP Systems Validation Engineer (12‑Month FTC)

Norgine

Hengoed

On-site

GBP 42,000 - 64,000

Full time

6 days ago

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Job summary

Norgine is seeking a Computer Systems Validation Engineer for a 12-month fixed-term contract in Hengoed, United Kingdom. You will ensure GxP-regulated computerized systems, equipment and validation documentation meet quality and regulatory requirements throughout the system lifecycle.

The role involves developing validation plans, risk assessments and test scripts; supporting audits; collaborating with Quality, Manufacturing, IT and external vendors to embed validation requirements and improve

Qualifications

Bachelor's degree or equivalent in computer systems, engineering or related discipline.
Experience with quality assurance methodologies, data collection and analysis, and project quality management.
Ability to interpret complex information and make sound decisions.
Strong collaboration and communication skills to raise compliance concerns.

Responsibilities

Plan, coordinate and carry out validation activities for GxP-regulated computerised systems.
Develop, review and maintain validation plans, risk assessments, protocols, test scripts and traceability matrices.
Perform system testing to ensure systems meet business, quality and regulatory requirements.
Support audits, inspections and regulatory enquiries with validation evidence.
Collaborate with Quality, Manufacturing, Engineering, IT and external vendors to embed validation throughout the lifecycle.