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ELIQUENT Life Sciences · Dayton, Ohio
Computer System Validation (CSV) Specialist – Consultant
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
User Requirement Specifications (URS)
Functional
Specifications (FRS)
Risk Assessments
Validation Plans
IQ/OQ/PQ protocols
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
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.
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
Ability to work independently and manage multiple priorities with minimal supervision.
Strong communication and cross-functional collaboration skills.
Preferred
Experience validating systems such as manufacturing and analytical systems, eQMS, LIMS, ERP, document management, and learning management systems.
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.
Details
| Company | ELIQUENT Life Sciences |
| Location | Dayton, Ohio |
| Type | FULL TIME |
| Niche | Computer and Mathematical Occupations |