Overview In this role you perform CSV for QC laboratory systems at the Canton site within a cGMP setting. You work independently to ensure validated computer systems meet regulatory expectations. You will write, review, and execute validation documents and support instrument validation across HPLC, TOC, UV-Vis, and FT-IR platforms. This position focuses on quality, compliance, and impactful validation work that supports manufacturing and testing workflows.
Responsibilities- Perform Computer System Validation across laboratory systems in QC
- Write, review, and execute validation documentation (Validation Plan, IQ, OQ, PQ, DSN, summary reports)
- Ensure CFR Part 11 compliance for electronic data systems
- Operate in a cGMP environment with minimal supervision
- Validate laboratory instruments (HPLC, TOC, UV-Vis, FT-IR) and related data systems
- Navigate Windows environments and basic scripting for validation tasks
- Collaborate with QA and cross-functional teams on validation activities
Key requirements- 2-4 years of Computer System Validation experience in a laboratory environment
- Strong experience writing, reviewing, and executing validation documentation
- Excellent understanding of CFR-Part 11 Compliance for Electronic Data Systems
- Knowledge of laboratory instruments (HPLC, TOC, UV-Vis, FT-IR)
- Good understanding of Windows OS (XP/Windows7) and basic scripting (VBScript) or similar
- Basic understanding of Microsoft SQL is a plus
- BS in Chemistry/Biology/Computer Science or related field with laboratory instrumentation experience in a cGMP environment
- independent and self-motivated
- detail-oriented
- strong communication and collaboration
- Computer System Validation
- Validation documentation (IQ/OQ/PQ, DSN, validation summary)
- CFR Part 11 compliance
