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Senior Computer Systems Validation (CSV) Specialist
Industry: Biopharmaceutical Manufacturing / Life Sciences
Work Setting: On-site | Portsmouth, New Hampshire, USA
Overview
A leading life sciences manufacturing organisation is seeking a Senior Computer Systems Validation (CSV) Specialist to support validation and compliance activities across regulated computerised systems within a cGMP environment.
This role will lead computer systems validation projects, ensure compliance with regulatory requirements, support quality management processes, and provide subject matter expertise for validation activities across manufacturing, engineering, and quality functions.
The successful candidate will play a key role in maintaining system compliance, supporting audits and inspections, and driving continuous improvement initiatives within a highly regulated environment.
Key Responsibilities
Computer Systems Validation
- Lead end-to-end computer systems validation activities throughout the system lifecycle.
- Author, review, and approve validation documentation including protocols, risk assessments, testing documentation, reports, and traceability records.
- Evaluate new and existing computerised systems to ensure compliance with internal procedures and regulatory requirements.
- Conduct system risk assessments and gap analyses, identifying compliance risks and recommending remediation strategies.
- Review change requests and validation impacts associated with system modifications.
Quality & Compliance
- Support Quality Management System activities including Change Controls, Deviations, CAPAs, and investigations.
- Ensure compliance with cGMP requirements, 21 CFR Part 11, and industry validation standards.
- Review engineering and technical documentation to assess validation and compliance impacts.
- Maintain validation procedures, standards, and documentation to support ongoing compliance.
Project Leadership
- Lead validation workstreams across multiple projects and initiatives.
- Coordinate validation activities with engineering, manufacturing, quality, and business stakeholders.
- Schedule validation activities and resources to meet project and operational timelines.
- Act as the primary CSV representative for validation-related projects.
Audit & Inspection Support
- Serve as a Computer Systems Validation subject matter expert during customer audits and regulatory inspections.
- Support audit preparation activities and provide validation documentation as required.
- Respond to validation-related findings and implement corrective actions where necessary.
Continuous Improvement
- Identify opportunities to improve validation processes, documentation, and compliance practices.
- Support implementation of validation best practices and industry standards.
- Mentor junior validation professionals and provide technical guidance across the organisation.
Requirements
- Bachelor’s degree in Computer Science, Engineering, Information Systems, or a related discipline.
- 3 years of Computer Systems Validation (CSV) experience.
- 3 years of experience working within a regulated cGMP environment.
- Strong knowledge of 21 CFR Part 11, GAMP, and computerised system validation principles.
- Experience authoring and reviewing validation lifecycle documentation.
- Knowledge of Change Control, Deviations, CAPA, and Quality Management Systems.
- Ability to manage validation projects independently and collaborate with cross-functional teams.
- Experience within pharmaceutical, biotechnology, medical device, or other regulated life sciences environments preferred.
Ideal Candidate
The ideal candidate combines strong technical validation expertise with a deep understanding of regulatory compliance within regulated manufacturing environments. They are comfortable leading validation initiatives, supporting inspections, managing quality records, and driving compliance across computerised systems throughout their lifecycle.