CSV Engineer- 12 months FTC

Norgine; Hengoed; Presencial; GBP 42 000 - 64 000; Tempo integral

Resumo da oferta

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

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

GxP knowledge

Analytical thinking

Documentation

Collaboration

Quality assurance

Formação académica

Bachelor's degree in computer systems/engineering

Descrição da oferta de emprego

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.

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.

Requirements

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.

Benefits

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