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Linesight

Lead CSA Estimator

Columbus, OH · On-site

$125K - $175K/yr

Overview As a Lead CAS Estimator at Linesight, you will lead highly experienced, culturally diverse, and passionate teams nurturing a strong social dynamic and a shared sense of achievement. You will ...

Lowe's

Part time Weekend - CSA

Columbus, OH · On-site

$14 - $19.25/hr

Notes of interest This is a customer-facing, sales-focused position, tasked with enhancing sales of outdoor power equipment (OPE). Associates in this position will concentrate on customer engagement ...

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Veeva LIMS SME Consultant / Senior Validation Engineer

Spadtek Solutions LLC

Columbus, OH • On-site

Other

This job post has expired 2 days ago. Applications are no longer accepted.

Job description

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.

Apply