GxP CSV Engineer – Life Sciences Compliance Expert

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

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.