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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # System Level Review (SLR) & Audit Trail Review (ATR) Consultant - GxP Laboratory Systems - **Company:** Alphanumeric Systems, Inc. - **Location:** Collegeville, PA, United States - **Salary:** $145,600.0 - $176,800.0 - **Contract:** Permanent contract - **Skills:** Microsoft Access, Audit Trail, System Configuration, Data Integrity, Electronic Signatures, Laboratory Information Management Systems, Chromeleon, System Testing, Computerised Systems, Information Technology, Veeva, GXP - **Published:** August 5, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=35d41e80a549766e ## About the Role * Bachelor's degree in Engineering, Computer Science, Chemistry, Biology, Life Sciences, or a related technical discipline. * Minimum 5 years of experience supporting GxP-regulated pharmaceutical, biotechnology, or life sciences environments. * Hands-on experience performing Computerized System Validation (CSV). * Experience conducting System Level Reviews (SLRs), Periodic Reviews, and/or Audit Trail Reviews (ATRs) for laboratory equipment or computerized systems. * Strong knowledge of: + GxP + FDA 21 CFR Part 11 + Data Integrity (ALCOA+) + Electronic Records and Electronic Signatures + Change Control and Risk Assessment * Experience supporting laboratory computerized systems and laboratory equipment. * Strong technical writing, documentation, and communication skills. Preferred Experience: Experience with one or more of the following systems is highly desirable: * Waters Empower * LabWare LIMS * LabVantage * Chromeleon * OpenLab * Electronic Laboratory Notebooks (ELN) * Veeva * Kneat * ValGenesis Preferred Skills: * Computerized System Validation (CSV) * Data Integrity * Audit Trail Reviews * System Level Reviews * Laboratory Compliance * Risk Assessment * CAPA * Change Control * Root Cause Analysis * GAMP 5 * Good Manufacturing Practice (GMP) * Laboratory Information Management Systems (LIMS) Why Join Us? This is an opportunity to support highly visible compliance initiatives within a global pharmaceutical organization. You'll work alongside cross-functional Quality, Validation, Engineering, and Laboratory teams on projects that directly impact regulatory compliance, data integrity, and inspection readiness. Please Note: This is a 100% onsite position located in Collegeville, PA. Candidates must be authorized to work in the United States on a W2 basis. We are unable to accept third-party candidates or provide sponsorship now or in the future. ## Description This role is ideal for a Computerized System Validation (CSV) professional with hands-on experience supporting laboratory equipment and computerized systems in a regulated GxP environment. The successful candidate will perform System Level Reviews, Audit Trail Reviews, and Data Integrity assessments while ensuring laboratory systems remain compliant, inspection-ready, and aligned with FDA regulatory expectations. Candidates with experience performing Periodic Reviews, Computerized System Reviews, or equivalent laboratory system compliance assessments are encouraged to apply. What you'll be doing: * Perform System Level Reviews (SLRs) for laboratory equipment and computerized systems. * Execute Audit Trail Reviews (ATRs) to evaluate system compliance, electronic records, and data integrity. * Assess laboratory systems for compliance with GxP, FDA 21 CFR Part 11, and applicable regulatory requirements. * Review audit trails, electronic records, user access, security controls, system configurations, and lifecycle documentation. * Identify data integrity risks, compliance gaps, and opportunities for remediation. * Author and review validation documentation, including risk assessments, validation plans, protocols, reports, periodic reviews, and change controls. * Support Computerized System Validation (CSV) activities throughout the system lifecycle. * Partner with Quality Assurance, Validation, Laboratory Operations, Engineering, and IT teams to ensure systems remain in a validated state. * Support internal audits, regulatory inspections, and inspection readiness initiatives. * Ensure validation deliverables meet established quality standards and project timelines. ## Related Videos - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [Slopquatting, API Keys, Fun with Fonts, Recruiters vs AI and more - The Best of LIVE 2025 - Part 2](https://www.wearedevelopers.com/videos/1765-slopquatting-api-keys-fun-with-fonts-recruiters-vs-ai-and-more-the-best-of-live-2025-part-2) - [Security Pitfalls for Software Engineers](https://www.wearedevelopers.com/videos/726-security-pitfalls-for-software-engineers) - [Navigating the Corporate Jungle: Life as a Developer in a large Company](https://www.wearedevelopers.com/videos/621-navigating-the-corporate-jungle-life-as-a-developer-in-a-large-company) ## Related Articles - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Best Companies to work for in London: Top 25 Companies in 2023](https://www.wearedevelopers.com/magazine/187-best-companies-to-work-for-in-london-top-25-companies-in-2023) - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [Best Coding Boot Camps in Germany](https://www.wearedevelopers.com/magazine/237-best-coding-boot-camps-in-germany) - [Where To Find Software Engineering Jobs](https://www.wearedevelopers.com/magazine/396-where-to-find-software-engineering-jobs) - [Data Analyst Salary in the UK](https://www.wearedevelopers.com/magazine/278-data-analyst-salary-in-the-uk)