Benchling Validation Consultant

Benchling Validation Consultant

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:

Deep expertise in validating GxP-regulated IT
systems within the Pharma/Life Sciences domain
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