Job Description

Job Title:- Benchling Validation Consultant

Job Location:- Remote

Long Term Contract

KEY RESPONSIBILITIES:

• Strong understanding of CSA (Computer Software Assurance)
• In-depth knowledge of GAMP 5, 21 CFR Part 11, and Annex 11 compliance requirements
• Hands-on experience with Benchling cloud-based LIMS platform
• Validation efforts for periodic SaaS/cloud releases, patches, upgrades, and enhancements
• Assess GxP impact of each release and update validation deliverables accordingly.
• Develop Validation Plans that align with the platform's release cycle and the system's intended use within a regulated (GxP) environment.
• Author and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for - Benchling upgrades, Module implementations, Configuration changes.
• Create Test Summary Reports, Risk assessments, Configuration verification and bench
• Ensure documentation captures testing details, deviation management, and defect traceability.
• Maintain a high approval rate through precise, inspection-ready documentation.
• Proficiency with tools like Veeva Vault (Docs/QMS), SNOW preferred.
• Excellent documentation skills with a track record of high approval rates and audit readiness
• Strong communication and stakeholder management skills across IT, QA, and business teams

Skills & Experience Required:

• Familiarity with QMS processes including deviation management, CAPA, and change control.
• Proven experience with Benchling or similar cloud-based ELN/LIMS platforms
• Strong command of CSA (Computer Software Assurance) principles
• Solid knowledge of GAMP 5, 21 CFR Part 11, Annex 11
• Prior experience managing validation efforts for cloud-based platforms with periodic releases.
• Proven ability to write and manage validation deliverables including Validation Plans, IQ/OQ/PQ protocols, Risk Assessments, Traceability Matrices, Test Scripts, and Summary Reports

Sandip Kumar
Sr. Tech Recruiter

Email:
sandip@stellentit.com

Telephone:
+1 321-641-0093

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