Senior Validation Engineer

Katalyst CRO; Columbus (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a seasoned validation professional to lead and support Veeva LIMS validation across the full lifecycle in Columbus, OH. You will collaborate with Quality, IT, and business stakeholders to ensure the system meets business and regulatory needs and maintains data integrity.

The role requires 5+ years in computerized system validation within GxP environments and a strong understanding of CSV/CSA, 21 CFR Part 11, EU Annex 11, and GAMP 5.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Veeva LIMS

Validation engineering

CSV/CSA methodologies

GxP requirements

Data integrity

Requirements gathering

Test protocols/scripts

Traceability matrices

Regulatory compliance

Project management

Education

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

Tools

Veeva LIMS

Job description

• 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.

Roles & Responsibilities

• 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.

Requirements:

• 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