Biotech and Pharmaceutical, Change Control, Communication Skills, Computer Systems, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Document Management, Fourier-Transform Infrared Spectroscopy (FTIR), GMP (Good Manufacturing Practices), GxP, Identify Issues, Laboratory, Laboratory Systems, Maintain Compliance, Performance Management, Process Validation, Quality Control, Sequencers, ServiceNow, Software Development Lifecycle (SDLC), System Lifecycle, System Validation, Systems Administration/Management, Systems Engineering, Validation Documentation, Writing Skills
Hello,
I hope you're doing well.
My name is Mahalakshmi, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a CSV Engineer (GxP Systems Engineer) based in Norwood, MA with one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at
mahalakshmi.n@intellectt.com
OR +1 (732) 737 8381
Role: CSV Engineer (GxP Systems Engineer)
Location: Norwood, MA
Role Overview:
Support validation, delivery, and administration of GxP laboratory and enterprise computerized systems. Work within the Digital Quality team to ensure system compliance, performance, and lifecycle management.
Key Responsibilities:
- Manage lifecycle of lab systems (HIAC, FTIR, TOC, Bioanalyzers, Sequencers) and enterprise systems (Chromeleon, LogiLab, SoftMax Pro).
- Translate business and technical requirements into digital lab system solutions.
- Lead and execute Computer System Validation (CSV) activities (URS, FRS, IQ/OQ/PQ, etc.).
- Author and maintain validation and compliance documentation.
- Act as system administrator for QC lab systems.
- Troubleshoot system issues and support incident resolution.
- Conduct periodic reviews, audit trail reviews, and user access reviews.
- Ensure GMP compliance and inspection readiness.
Basic Qualifications:
- Bachelor's degree in STEM (or related field)
- 4+ years in cGxP environment
- Experience with CSV documentation and lifecycle activities
- Familiarity with QMS, Document Management, ServiceNow
- Experience with KNEAT or similar SDLC tools
- Knowledge of change controls, deviations, and CAPA processes
Preferred Skills:
- Experience with lab instruments (TOC, Bioanalyzers, Spectramax)
- Experience with systems like Chromeleon, LabX
- Background in pharma/biotech or regulated industries
- Experience with data integration and lab connectivity
- Strong communication and ability to work cross-functionally.
Thanks & Regards,
Mahalakshmi
Junior Recruiter
Intellectt Inc
mahalakshmi.n@intellectt.com
Direct: +1 (732) 737 8381