Computer System Validation Engineer

Job Description

As a Computer System Validation (CSV) Engineer, you will join our [Location] team to support our activities within the Pharmaceutical & Life Sciences sector. You will support the validation and compliance of GxP-regulated computerised systems across manufacturing, quality and laboratory environments. Working closely with Quality, Engineering, Manufacturing, IT and external vendors, you will ensure systems are fit for purpose, compliant with regulatory requirements and maintain the highest standards of data integrity throughout the system lifecycle.

• Location: Wales
• On Site: Full time
• Clearance: Clearable
• Experience Level: Mid- Level (5-9 years of experience)

Key Responsibilities:

• Plan, coordinate and execute validation activities for new and existing GxP-regulated computerised systems.
• Develop, review and maintain validation documentation including validation plans, protocols, test scripts, risk assessments, reports and traceability matrices.
• Perform system testing, verification and validation activities to ensure compliance with business, quality and regulatory requirements.
• Support audits, inspections and regulatory enquiries through the provision of validation documentation and evidence.
• Assess system changes and contribute to change control activities throughout the system lifecycle.
• Work collaboratively with Quality, Manufacturing, Engineering, IT and external vendors to ensure validation requirements are implemented effectively.
• Support data integrity initiatives and ensure systems remain compliant with applicable regulations and industry standards.
• Contribute to continuous improvement activities, validation procedures and best-practice standards.

Qualifications

Required Skills:

• Computer System Validation (CSV)
• GxP-Regulated Environments
• Validation Planning & Execution
• Requirements Verification & Testing
• Risk Assessments & Traceability Matrices
• Quality Assurance & Compliance
• Documentation Review & Report Writing
• Data Collection, Analysis & Interpretation
• Change Control & Lifecycle Management
• Stakeholder & Vendor Management
• Audit & Inspection Support
• Strong Communication & Problem-Solving Skills

Required Qualifications:

• A Bachelor’s or Master’s degree in Engineering, or equivalent military experience.
• Experience working within a regulated environment supporting validation, quality or compliance activities.
• Experience creating and executing validation deliverables including protocols, test scripts, risk

Desirable Skills:

• Knowledge of GAMP 5, EU GMP Annex 11 and 21 CFR Part 11.
• Experience with regulated systems including ERP, MES, LIMS, Manufacturing Execution Systems or Laboratory Systems.
• Understanding of Data Integrity principles (ALCOA+).
• Experience supporting pharmaceutical, biotechnology, medical device or life sciences organisations.
• Knowledge of Quality Management Systems (QMS), deviation management and CAPA processes.

Additional Information

Why join us? 

We bring together entrepreneurial, tech-driven people to deliver innovative solutions for leading companies.

At ALTEN, you’ll work on exciting projects, supported by ongoing learning, mentoring, and clear career development tailored to your goals.

Join a passionate team and help build tomorrow, today.

In short you get: 

• A personalised career path and a rewarding management style 
• A huge diversity of engineering projects and industries
• Private Medical Insurance
• Cycle & Tech Scheme 
• Employee assistance programme
• Life insurance & Pension Scheme
• Social atmosphere, regular gatherings & team buildings
• Flexible way of working (role dependent)

We are proud to support the Armed Forces Covenant & actively encourage applications from members of the Armed Forces community, including veterans, reservists, service leavers, and military spouses/partners. We recognise the value of military skills and experience and are committed to ensuring that no applicant is unfairly disadvantaged during our recruitment and selection processes. 

ALTEN is committed to fostering a diverse and inclusive workplace and values the strength that comes from a global mix of backgrounds and perspectives. We welcome applications from all suitably qualified candidates, regardless of background or protected characteristics under the Equality Act 2010. If you require any reasonable adjustments during the recruitment process, please let us know. 

This role may require you to have or be willing to go through Security Clearance. As part of the onboarding process candidates will be asked to complete a Baseline Personnel Security Standard; details of the evidence required to apply may be found on the government website Gov.UK. If you are unable to meet this and any associated criteria, then your employment may be delayed, or rejected . Details of this will be discussed with you at interview.