Computer System Validation (CSV) Engineer

ALTEN; Greater London; On-site; GBP 55,000 - 75,000; Full time

Benefits offered by this job

Private MedicalInsurance

Employee assistance programme

Life insurance & Pension Scheme

Social atmosphere, team events

Flexible working (role dependent)

Job summary

ALTEN is hiring a Computer System Validation (CSV) Engineer to join the London area team supporting Pharmaceutical & Life Sciences. You will validate and ensure the compliance of GxP-regulated systems across manufacturing, quality and lab environments, partnering with Quality, IT and external vendors to uphold data integrity.

The role emphasizes validation planning, protocol execution, and audit support, with a strong focus on regulatory standards, quality, and continuous improvement.

Qualifications

• Experience in GxP-regulated environments.
• Experience validating computerised systems.
• Knowledge of GAMP 5, EU GMP Annex 11 and 21 CFR Part 11.
• Experience with ERP, MES, LIMS or Lab systems.
• Understanding of ALCOA+ data integrity.
• Experience supporting pharmaceutical/life sciences organisations.

Responsibilities

• Plan, coordinate and execute validation activities for GxP-regulated computerised systems.
• Develop, review and maintain validation documentation including plans, protocols, test scripts, risk assessments and reports.
• Perform system testing, verification and validation to ensure compliance.
• Support audits, inspections and regulatory inquiries with documentation and evidence.
• Assess system changes and contribute to change control across the lifecycle.
• Collaborate with Quality, Manufacturing, Engineering, IT and vendors to implement validation.
• Support data integrity initiatives and ensure regulatory compliance.
• Contribute to continuous improvement of validation procedures and best practices.

Skills

CSV

GxP

Validation

Test Scripts

Risk Assessments

QA & Compliance

Documentation

Data Integrity

Change Control

Audit Support

Communication

Education

Engineering Degree

Military Experience

Job description

• Full-time
• Contract Type: Permanent
• Region: London

Company Description

ALTEN is a global engineering and technology consultancy operating across over 35 countries worldwide. We partner with industry leaders across sectors including Aeronautics, Aerospace, Defence, Naval, Automotive, Energy, Rail, IT and many more to deliver innovative engineering solutions that drive technological advancement & support sustainable transformation.

Our teams of passionate and agile engineers work on cutting-edge projects that shape the future of technology and sustainability. At ALTEN, we empower talented engineers to innovate, solve complex challenges, and deliver impactful solutions that build tomorrow’s world—today.

Join us and start building tomorrow’s world today!

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.

• On Site: Full time
• 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
• Audit & Inspection Support
• Strong Communication & Problem-Solving Skills

Required Qualifications:

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

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.

• A personalised career path and a rewarding management style
• A huge diversity of engineering projects and industries
• Private MedicalInsurance
• 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.