Computer System Validation; CSV) Engineer

Position: Computer System Validation (CSV) Engineer
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
  , 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
• 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.

Jo…