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.