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Biotech Validation Jobs in Ohio (NOW HIRING)

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices ...

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices ...

Validation Engineer

Cincinnati, OH · On-site

$70 - $90/hr

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the ...

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the ...

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the ...

Five to seven years of validation experience in pharmaceutical, biotechnology, or regulated manufacturing environments; or * Equivalent combination of education and experience * Strong technical ...

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Veeva LIMS SME Consultant / Senior Validation Engineer

Spadtek Solutions LLC

Columbus, OH • On-site

Other

This job post has expired today. 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.