CSV Specialist, GxP Systems & Compliance

Alimentiv; United States; Remote; USD 69,000 - 115,000; Full time

Benefits offered by this job

Education Reimbursement program

Monthly Cell Phone and Remote Work Stl

Office setup allowance

Working while visiting program

Flexible Summer Hours

Employee referral incentive

Alimentiv Trust after 1 year

Mentorship program (Alimentorship)

Job summary

Alimentiv, a global CRO focused on GI therapeutics, seeks a Computer System Validation (CSV) Specialist to lead validation of GCP-regulated systems. You will partner with IT, Quality, and business teams to ensure compliant, reliable solutions from planning through execution.

You will develop validation documents, coordinate testing, and manage defects while guiding change control and regulatory alignment. This role emphasizes collaboration and ongoing compliance in a regulated environment.

Qualifications

• 3–5 years of relevant experience in validating GCP-regulated computerized systems or similar regulated environments.
• Experience validating GCP-regulated systems in pharma/biotech/medical device or equivalent industries.
• Strong understanding of quality system principles, including validation, documentation, change control, training, and audit readiness.
• Proven ability to collaborate effectively in cross-functional and matrixed environments.
• Excellent written and verbal communication skills; able to document, present, and explain regulatory information clearly.

Responsibilities

• Execute validation activities for computerized systems in compliance with GxP, 21 CFR Part 11, and applicable regulations.
• Develop and maintain validation documentation: validation plans, test scripts, traceability matrices, summary reports, release docs.
• Partner with IT, QA, business stakeholders, and external vendors to define validation strategies and ensure project success.
• Coordinate and oversee validation testing activities with appropriate documentation.
• Manage defects, deviations, and incidents identified during testing including triage and closure.
• Facilitate review, approval, execution, and post-execution management of validation docs.
• Train project teams on validation procedures, tools, and standards; support change management for validated systems.

Skills

Communication skills

Cross-functional collaboration

Quality system understanding

SDLC familiarity

Education

Bachelor’s degree in Computer Science, Information Technology, Engineering, Software Development, or related field

Tools

Automated testing tools

Enterprise validation technologies

Job description

Alimentiv, a global CRO focused on GI therapeutics, seeks a Computer System Validation (CSV) Specialist to lead validation of GCP-regulated systems. You will partner with IT, Quality, and business teams to ensure compliant, reliable solutions from planning through execution.

You will develop validation documents, coordinate testing, and manage defects while guiding change control and regulatory alignment. This role emphasizes collaboration and ongoing compliance in a regulated environment.