CSV Engineer- 12 months FTC

Norgine; Hengoed; On-site; GBP 42,000 - 64,000; Full time

Job summary

Norgine is seeking a Computer Systems Validation Engineer in Hengoed for a 12-month fixed-term contract. You will guide validation of GxP-regulated computerised systems, ensuring data integrity and regulatory compliance across the system lifecycle.

You will develop validation plans, perform testing, support audits and collaborate with Quality, Manufacturing, Engineering and IT teams to embed validation requirements with a risk-based mindset.

Qualifications

• Bachelor's degree in computer systems, engineering or related discipline.
• Experience with QA methodologies, data collection and analysis.
• Experience in planning, organisation and project quality management.
• Strong communication and collaboration skills.

Responsibilities

• Plan, coordinate and carry out validation activities for new and existing GxP-regulated computerised systems.
• Develop, review and maintain validation plans, risk assessments, protocols, test scripts, reports and traceability matrices.
• Perform system testing and verification to confirm that systems meet defined business, quality and regulatory requirements.
• Support audits, inspections and regulatory enquiries by providing validation evidence.
• Work with Quality, Manufacturing, Engineering, IT and external vendors to assess changes and embed validation requirements throughout the system lifecycle.
• Contribute to validation standards, processes, best practice and continuous improvement.

Skills

Quality assurance

Data analysis

Planning & organisation

Requirements verification

Communication

Collaboration

Education

Bachelor's degree in computer systems/engineering or related

Job description

Want a 3D career? Join Norgine.

At Norgine, our colleagues Dare to be different, Drive to achieve their goals and Develop themselves and their community. This is what we call a 3D career, offering ongoing development within a supportive and inclusive environment.

Norgine: Transforming Healthcare, Backed by Over a Century of Expertise.

We have an exciting opportunity for a Computer Systems Validation Engineer to join Norgine in Hengoed.

The Role:

In this role, you will help ensure that Norgine's GxP-regulated computerised systems, equipment, validation documentation and associated processes meet applicable quality and regulatory requirements. You will provide practical validation expertise throughout the system lifecycle and apply risk-based principles to support compliance, data integrity and operational effectiveness.

This is a 12-month fixed-term contract (FTC) role

Key Responsibilities:

• Plan, coordinate and carry out validation activities for new and existing GxP-regulated computerised systems.
• Develop, review and maintain validation plans, risk assessments, protocols, test scripts, reports and traceability matrices.
• Perform system testing and verification to confirm that systems meet defined business, quality and regulatory requirements.
• Support audits, inspections and regulatory enquiries by providing validation evidence.
• Work with Quality, Manufacturing, Engineering, IT and external vendors to assess changes and embed validation requirements throughout the system lifecycle.
• Contribute to validation standards, processes, best practice and continuous improvement.

Skills and experience required

• A bachelor's degree, or equivalent qualification or experience, in computer systems, engineering or a related discipline.
• Experience working with relevant procedures or systems.
• Competence in quality assurance methodologies, review and reporting, data collection and analysis, planning and organisation, requirements verification and project quality management.
• Ability to interpret complex information, make sound decisions and identify appropriate actions.
• Strong collaboration and communication skills, with the confidence to raise compliance concerns when required.
• A structured, accountable approach to documentation, testing and delivery.

Beneficial experience

• Working knowledge of GxP requirements, data-integrity principles and relevant guidance, including GAMP 5, EU GMP Annex 11 and 21 CFR Part 11.
• Experience producing and executing validation deliverables, including risk assessments, protocols, test scripts and validation reports.
• Familiarity with manufacturing, laboratory, quality, ERP, MES, LIMS or other regulated computerised systems.

Bring our values to life

• Drive: Take ownership, focus on business priorities and deliver results.
• Dare: Challenge respectfully, explore new ideas and address difficult issues constructively.
• Develop: Build strong connections, collaborate across teams and value different perspectives.

Why join us?

At Norgine, you'll join an inclusive environment where different perspectives are valued. You'll have opportunities to develop your career while contributing to work that makes a meaningful difference to patients' lives.

This job advert is a summary of the typical functions of the job not an exhaustive or comprehensive list of all possible responsibilities, tasks, and duties. Norgine reserves the right to change responsibilities to meet business and organisational needs, as necessary.

AI Transparency Statement:

To help us create clear and engaging job adverts, we may use AI-assisted drafting based on an approved job description. Every advert is reviewed and approved by our recruitment team before publication to ensure it accurately reflects the role and our organisation.

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.