Lead/Senior Computer System Validation Specialist
Key Responsibilities
The Lead/Senior CSV Specialist serves as the Subject Matter Expert (SME) for computerized system compliance. This role is responsible for defining the validation strategy for enterprise systems (e.g., SAP, LIMS, TrackWise). You will lead the Risk-Based Approach (GAMP 5) to ensure software and cloud-based applications meet FDA regulatory requirements.
Validation Planning
Develop Validation Master Plans (VMPs) and Validation Plans for GxP systems, determining the risk-based validation approach (e.g., GAMP Category 3 vs. Category 5).
Risk Management
Facilitate Functional Risk Assessments (FRA) to identify potential failure modes in software configuration and data handling.
21 CFR Part 11 Compliance
Conduct specific assessments on systems to ensure electronic signature and audit trail functionality meets federal standards.
Change Control
Act as the Quality approver for IT Change Controls, assessing the impact of patches, updates, or configuration changes on the validated state.
Deliverable Management
Author and approve high-level deliverables including User Requirement Specifications (URS), Functional Specifications (FS), and Traceability Matrices (RTM).
Qualifications
Education
B.S. or M.S. in Computer Science, Information Technology, or Engineering.
Experience
10+ years in CSV within the Pharmaceutical or Biotech industry.
Technical Mastery
1. Conduct specific assessments on systems to ensure electronic signature and audit trail functionality meets federal standards.
2. Deep understanding of ISPE GAMP 5 (2nd Edition) guides.
3. Experience validating SaaS/Cloud environments (Azure, AWS) and Enterprise systems (ERP, MES, LIMS).
4. Deep practical experience and knowledge of SDLC methodologies (Waterfall and Agile).
Soft Skills
Ability to translate technical IT issues into Quality/Compliance language for stakeholders.
Join Our Dynamic Team Today
We’re looking for passionate individuals ready to make an impact in software compliance and quality assurance.