Computer Systems Validation Specialist (Part-Time)

Computer System Validation (CSV) Specialist – Consultant

Location: Remote with preference for 1–2 days onsite per week in the greater Cincinnati, Ohio area.

Schedule: Part-time, approximately 20 hours per week

Duration: 3 months

Start: ASAP

Position Overview

We are seeking an experienced Computer System Validation (CSV) Specialist to support the remediation of a computer system validation program within a regulated life sciences environment.

The ideal candidate will have deep, hands-on CSV experience and be capable of independently developing complete validation lifecycle documentation, procedures, and templates from scratch. This individual should be comfortable working with minimal direction and applying a practical, risk-based approach aligned with GAMP 5 (Second Edition) and FDA Computer Software Assurance (CSA) principles.

Key Responsibilities

• Independently author and maintain computer system validation lifecycle documentation, including:


• User Requirement Specifications (URS)


• Functional Requirements Specifications (FRS)


• Risk Assessments


• Validation Plans


• IQ/OQ/PQ protocols


• Requirements Traceability Matrices (RTM)


• Validation Summary Reports (VSR)


• Develop computer system lifecycle SOPs and standardized validation templates.


• Manage test deviations and incidents, including impact assessments, root cause analysis, and resolution documentation.


• Support change control and periodic reviews to maintain systems in a validated state.


• Apply GAMP 5 and CSA risk-based approaches to validation activities.


• Ensure compliance with requirements related to electronic records, electronic signatures, audit trails, security, and data integrity.


• Evaluate supplier documentation and support vendor assessments.


• Facilitate requirements-gathering sessions, risk assessments, and document reviews.


• Partner with Quality, IT, system owners, business users, and external vendors.


• Communicate validation risks, issues, and project status to key stakeholders.

Required Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, Information Systems, or a related field.


• 5+ years of hands-on CSV experience in a regulated pharmaceutical, biotechnology, medical device, or related life sciences environment.


• Demonstrated experience independently authoring complete validation lifecycle packages from scratch.


• Experience developing CSV SOPs, procedures, and document templates.

Strong working knowledge of:

• GAMP 5, Second Edition


• FDA Computer Software Assurance (CSA)


• 21 CFR Part 11


• EU GMP Annex 11


• Data integrity / ALCOA+ principles


• Risk-based validation approaches


• Strong technical writing and documentation skills.


• Ability to work independently and manage multiple priorities with minimal supervision.


• Strong communication and cross-functional collaboration skills.

Preferred Qualifications

• Experience validating systems such as manufacturing and analytical systems, eQMS, LIMS, ERP, document management, and learning management systems.


• Experience with cloud-hosted and SaaS platforms, including Veeva Vault.


• Experience with electronic validation or test management tools.


• Experience supporting regulatory inspections and audits.


• Previous consulting or multi-client experience.

Additional Details

This is a part-time consulting opportunity at approximately 20 hours per week. Candidates who can support 1–2 days onsite per week in the greater Cincinnati, Ohio area are preferred.