Senior Validation Engineer

Job Title

Lead/Support a Veeva LIMS implementation and the 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 the LIMS meets business and regulatory needs

Support Veeva LIMS configuration, functional testing, integration testing, user acceptance testing, and defect resolution

Apply risk-based CSV/CSA principles and applicable GxP requirements to ensure the validated state of the system is maintained

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

Participate in system change control, deviations, CAPAs, periodic reviews, and other lifecycle activities following implementation

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

Ensure validation activities comply with applicable regulatory expectations, company procedures, and industry practices such as 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

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

5+ years of experience in computerized system validation, quality, or validation engineering within pharmaceutical, biotechnology, or other GxP-regulated environments

Demonstrated experience with Veeva LIMS implementation, validation, or lifecycle management

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

Experience developing and executing validation/testing documentation, including requirements, risk assessments, test protocols/scripts, traceability, and validation reports

Strong understanding of 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable data integrity principles

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