Senior Computer System Validation Specialist

🔥 3 minutes ago

🗽 New York – Remote

🗽 New York – Remote

💵 $105k - $130k / year

⏰ Full Time

🟠 Senior

👻 Ghost score 0%

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ACM Global Laboratories

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

ACM Global Laboratories is a leading provider of clinical trial testing services, supporting clinical trials globally in over 65 countries. The company offers a range of bioanalytical services, including small and large molecule analysis, biomarker analysis, and various laboratory testing solutions such as routine safety testing, flow cytometry, and advanced sample tracking. ACM Global Laboratories is recognized for its expertise in bioanalysis and toxicology services, ensuring high sensitivity and accuracy in drug and metabolite measurements across diverse biological samples. The company is dedicated to delivering actionable clinical insights and reliable toxicology services to healthcare providers, partnering with clinical trials to optimize development projects through state-of-the-art laboratory services, specimen management, and global logistics.

📋 Description

• Lead risk-based validation and assurance activities for GxP-regulated computerized systems throughout their lifecycle • Provide technical leadership in validation strategy, execution, quality review, audit and inspection readiness • Serve as a subject matter expert in CSV/CSA, SDLC, data integrity, electronic records/signatures, and regulatory requirements • Author, review, or approve validation lifecycle deliverables, including risk assessments, validation or assurance plans, specifications, testing protocols, UAT evidence, traceability matrices, summary reports, periodic reviews, change impact assessments, migration, archival, decommissioning, and retirement documentation • Provide IT Quality and Compliance oversight for computerized systems, SDLC activities, validation deliverables, change controls, and lifecycle processes • Support audits, inspections, audit responses, CAPAs, deviations, remediation plans, and validation-related observations • Support procurement, implementation, configuration, validation, operational use, change control, periodic review, incident/deviation support, migration, archival, and retirement • Ensure validated systems remain in a state of control through change assessment, regression testing, periodic review, access/security review, backup/restore review, data integrity review, and documentation maintenance • Provide senior-level review and guidance for change controls, impact assessments, validation strategy decisions, test planning, evidence review, and release readiness • Provide technical leadership, coaching, and mentoring to CSV/CSA Specialists and cross-functional project teams • Support development and improvement of validation procedures, templates, guidance documents, training materials, metrics, and operating rhythms • Facilitate cross-functional meetings and communications related to validation strategy, compliance expectations, audit readiness, and lifecycle deliverables • Perform other duties as assigned

🎯 Requirements

• Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or related field OR equivalent combination of education and relevant experience • 5+ years of CSV, CSA, IT quality, software validation, change control, SDLC, or GxP computerized systems experience • Strong knowledge of computerized system validation, CSA, GAMP 5, SDLC, GxP, 21 CFR Part 11, EU Annex 11, data integrity, and e-record/e-signature expectations • Strong working knowledge of validation lifecycle deliverables and risk-based validation practices • Ability to interpret regulatory expectations and apply them pragmatically to system risk, intended use, and business impact • Strong technical writing, documentation review, inspection-readiness, analytical, prioritization, facilitation, and communication skills • Experience leading validation strategy and deliverable execution for laboratory, quality, clinical, enterprise, infrastructure, data, or integration systems • Experience supporting audits, inspections, CAPAs, deviations, remediation activities, SDLC reviews, change controls, testing evidence, data integrity controls, and lifecycle records • Experience mentoring or providing technical guidance to less senior validation or quality resources • Ability to lead complex validation activities across multiple systems, projects, stakeholders, and priorities • Ability to work remotely; East Coast preferred