About this opportunity
Eliquent Life Sciences lists this Computer Systems Validation Specialist (Part-Time) opportunity in city of dayton, Ohio. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Computer System Validation (CSV) Specialist – Consultant
Learn more about the general tasks related to this opportunity below, as well as required skills.
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. xzgxqkn Candidates who can support 1–2 days onsite per week in the greater Cincinnati, Ohio area are preferred.
Worksite address
city of dayton, OH, 45424, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.