What are the responsibilities and job description for the CSV Analyst position at Brooksource?
Job Title: Computer System Validation (CSV) Analyst
Location: Concord Manufacturing Site (Onsite)
Employment Type: [Long term Contract]
Overview
We are seeking a Computer System Validation (CSV) Analyst to support a newer manufacturing site in Concord. This role will be responsible for the creation, execution, and maintenance of site-level CSV documentation and validation deliverables in a regulated GMP environment. The ideal candidate has hands-on experience validating manufacturing and quality systems and is comfortable supporting a growing site with developing processes.
Key Responsibilities
- Own the creation, maintenance, and lifecycle management of local CSV validation deliverables for the Concord site
- Author site-level validation documentation, including:
- Site Validation Agreements and Validation Reports
- Security Plan and Security Administration documentation
- Business Continuity Plan (BCP) and Disaster Recovery Plan (DRP)
- Develop and execute Installation Verification Instructions (IVI) and IQ/OQ documentation for validated systems
- Create and maintain validation Test Plans as required based on system risk and GxP impact
- Author and execute ALM test scripts, ensuring full traceability to requirements
- Support quality and IT processes by utilizing ServiceNow and TrackWise to manage:
- Change Requests
- Incidents
- Deviations / Problems
- Partner cross-functionally with IT, Quality, Engineering, and Manufacturing teams to support system implementations and changes
- Ensure all validation activities comply with applicable regulations (21 CFR Part 11, GAMP 5, internal SOPs)
Required Qualifications
- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related discipline (or equivalent experience)
- 2 years of hands-on Computer System Validation (CSV) experience in a regulated manufacturing environment (pharma, biotech, medical device, etc.)
- Strong experience authoring CSV documentation (IQ/OQ, test scripts, validation plans, reports)
- Working knowledge of ServiceNow and TrackWise (change management, incidents, and problem resolution)
- Familiarity with ALM tools for test script management
- Understanding of GxP, data integrity, and 21 CFR Part 11 requirements
- Strong documentation skills and attention to detail
Nice to Have
- Experience supporting startup or greenfield manufacturing sites
- Exposure to MES, LIMS, ERP, or manufacturing automation systems
- Prior experience helping establish or mature CSV processes at a new site
What Success Looks Like
- Validation documentation is audit‑ready and aligned with regulatory and internal standards
- Systems are validated efficiently without delaying operations at a growing site
- Strong collaboration with Quality and IT stakeholders during system changes and implementations
Salary : $65 - $75