Validation
Job Description
- 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
Job Requirements
- 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
Meet Your Recruiter
Erin Hoke
My career began in the hospitality industry, but I sought a change for better work-life balance and family considerations. I moved into the world of recruiting in 1999, I started in light industrial roles and gradually specialized in contract and permanent placements across a wide range of technical industries.
In 2006, I co-founded Recruiting Resources with my father, focusing on professional services and human resources staffing for both small and national companies. In 2011, I became an independent recruiter, partnering with a small Firm in the Maryland area where I concentrated on sourcing talent primarily for the Life Sciences industry but also expanded into non-technical areas.
Throughout my career, I have valued personal connections and helping individuals find positions that align with their expertise and lifestyle. My journey reflects adaptability, entrepreneurship, and a passion for facilitating meaningful career opportunities for others. I joined Lloyd Staffing in Aug 2024 to specialize again in Life Sciences.
In my free time, I spend most of my time with my son. We have become quite the fishermen over the past 5 years.