Senior Validation Engineer

SENIOR VALIDATION ENGINEER -- Abbott Laboratories / Columbus, OHSupport validation program for Strategic Capacity Expansions within Nutrition division for large-scale capital projects. Define and align validation strategies for capital investments across all design phases. Advise on validation, design control strategies, and changes to products, processes, and equipment. Lead project validation and engineering activities. Define metrics to review progress, adherence, and compliance of validation and design control processes according to FDA regulations and guidelines. Resolve conflicts between project completion and policy requirements for compliant outcomes. Complete validation resource planning, scheduling, and support structure, in conjunction with Project Manager (PM). Author, review, and approve validation deliverables in association with the validation V-model. This includes but is not limited to System Impact Assessments, Risk Analyses (RA) such as Failure Mode and Effects Analysis (FMEA), Factory acceptance tests, Installation Qualifications (IQ), Operational Qualification (OQ), Performance Qualifications (PQ), cleaning validation, executions, deviation logs, Trace Matrix, and validation summary reports. Apply compliant product/process changes, in conjunction with Technical, Engineering, Quality, and Research and Development (R&D). Train and mentor employees on Good Documentation Practices (GDPs), Good Manufacturing Practices (GMP), validation requirements, and activities. Review validation methods and protocols, test methods, statistical analysis methods and specification derivation and assignment. Advise as a Subject Matter Expert (SME) for validation, design control processes, statistical sampling plans, Design of Experiments (DOE), and FMEAs. Review root causes of unexpected outcomes and define compliant solutions, in conjunction with the team. Advise with strategic decisions for validation encompassing all project phases and resource allocation. Review and approve change processes, validation packages, and design control documentation. Use and improve validation and design control policies, in conjunction with corporate, divisional, and capacity expansion teams.Bachelor's or foreign equivalent degree in Engineering, Life Sciences, Chemistry or closely related field of study with at least 5 years of progressive professional quality engineering or validation experience in medical device manufacturing, nutritional product, or related regulated industries. In the alternative, will accept a Master's degree with at least 3 years of professional quality engineering or validation experience in medical device manufacturing, nutritional products, or related regulated industries. Each alternative requirement must possess at least 3 years of professional experience in: (i) authoring, reviewing, and approving validation deliverables, including Risk Analyses (RA), Installation Qualifications (IQ), Operational Qualification (OQ), Performance Qualifications (PQ), executions, deviation logs, Trace Matrix, and validation summary reports; u00a0(ii) training and mentoring employees on Good Documentation Practices (GDPs), validation requirements, and activities; (iii) reviewing validation methods and protocols, test methods, statistical analysis methods and specification derivation and assignment. Employer will accept any suitable combination of education, training, or experience.An EOE. 40 hrs/wk. Send resumes to or by mail to Abbott Laboratories, Attn: 26J14A, Willis Tower, 233 S. Wacker Dr., Floor 26, Dept. 32, Chicago, IL 60606. Refer to ad code: ABT-0124-ES.

Created: 2025-09-29