Remote GxP CSV Specialist — Systems Validation

Alimentiv; England; On-site; GBP 52,000 - 86,000; Full time

Benefits offered by this job

Education Reimbursement

Monthly Cell Phone and Remote Work 0

Office setup allowance

Working while visiting program

Flexible Summer Hours Program

Employee referral incentive

Alimentiv Trust benefits after 1 year

Mentorship program and social events

Job summary

Alimentiv, a global CRO, seeks a Computer System Validation Specialist for a 12-month term to validate GCP-regulated systems. You will lead validation activities from planning to execution, partnering with IT, Quality, and business teams to deliver compliant, reliable solutions.

The role requires a Bachelor's degree and 3–5 years in CSV, experience with GxP and 21 CFR Part 11, strong documentation and communication, and the ability to collaborate in cross-functional teams.

Qualifications

• Bachelor's degree and 3–5 years CSV experience.
• Experience validating GCP-regulated computerized systems and software in regulated industries.
• Strong understanding of quality system principles: validation, documentation, change control, audit readiness.
• Proven ability to collaborate in cross-functional environments with internal and external stakeholders.
• Excellent written and verbal communication, ability to document and explain technical/compliance info.

Responsibilities

• Execute validation activities for computerized systems in compliance with GxP, 21 CFR Part 11, and regulatory requirements.
• Develop and maintain validation documentation: plans, scripts, traces, reports, release docs.
• Partner with IT, QA, business stakeholders and vendors to define validation strategies.
• Coordinate and oversee validation testing, ensuring requirements are tested and documented.
• Manage defects, deviations, and incidents; triage, resolve, and document closures.
• Facilitate reviews, approvals, execution, and post-execution management of validation docs.
• Train and support project teams on validation procedures and standards.
• Provide guidance on change management for validated systems and evolving regulations.

Skills

GCP validation

Cross-functional collaboration

Documentation

Regulatory compliance

SDLC familiarity

Education

Bachelor's degree in CS/IT/Engineering or related field

Tools

Automated testing tools

Enterprise validation technologies

SDLC tools

Job description

Alimentiv, a global CRO, seeks a Computer System Validation Specialist for a 12-month term to validate GCP-regulated systems. You will lead validation activities from planning to execution, partnering with IT, Quality, and business teams to deliver compliant, reliable solutions.

The role requires a Bachelor's degree and 3–5 years in CSV, experience with GxP and 21 CFR Part 11, strong documentation and communication, and the ability to collaborate in cross-functional teams.