Title : Veeva LIMS SME Consultant / Senior Validation Engineer

Location: Columbus, OH – Onsite

Job Description:

We are seeking an experienced Veeva LIMS SME Consultant / Senior Validation Engineer to support a Veeva LIMS implementation and validation activities within a GxP-regulated environment.

The ideal candidate will have strong hands-on experience with Veeva LIMS, Computer System Validation (CSV)/Computer Software Assurance (CSA), and pharmaceutical/biotechnology validation practices.

Responsibilities:

• Lead/support Veeva LIMS implementation and validation activities throughout the system lifecycle, from requirements and design through testing, deployment, and validation closeout.

• Develop and/or review validation deliverables including URS, risk assessments, validation plans, test scripts, traceability matrices, validation summary reports, and SOPs.

• Partner with Quality, Laboratory, IT, Business Process Owners, and system stakeholders to define requirements and ensure compliance with business and regulatory needs.

• Support Veeva LIMS configuration, functional testing, integration testing, UAT, and defect resolution.

• Apply risk-based CSV/CSA principles and applicable GxP requirements to maintain the validated state of the system.

• Support data migration, interfaces, integrations, and related systems as part of the LIMS implementation.

• Participate in change control, deviations, CAPAs, periodic reviews, and other system lifecycle activities.

• Provide technical and validation expertise during implementation meetings, workshops, testing activities, and issue resolution.

• Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles.

• Support inspection and audit readiness by ensuring complete, accurate, and traceable validation documentation.

Required Qualifications:

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical discipline.

• 5 years of experience in CSV, CSA, quality, or validation engineering within pharmaceutical, biotechnology, or other GxP-regulated environments.

• Hands-on Veeva LIMS implementation, validation, or lifecycle management experience is required.

• Strong understanding of CSV/CSA methodologies, GxP requirements, risk-based validation, and data integrity.

• Experience developing and executing validation/testing documentation.

• Strong knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5.

• Strong project management, organizational, communication, and problem-solving skills.

• Must be willing to work onsite in Columbus, OH.