6487 - Veeva LIMS SME Consultant / Senior Validation Engineer

United States·Indianapolissenior

QA & TestingValidation Engineer

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Quick Summary

Key Responsibilities

Lead/Support a Veeva LIMS implementation and the validation activities throughout the system lifecycle, from

Technical Tools

QA & TestingValidation Engineer

Description

We empower and support our colleagues
We commit to client success at every turn
We have the courage to do the right thing
We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Responsibilities

~1 min read

→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

~2 min read

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

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range

$85,470—$136,225 USD

Benefits

Why Choose Verista?

High growth potential and fast-paced organization with a people-focused culture
Competitive pay plus performance-based incentive programs
Company-paid Life, Short-Term, and Long-Term Disability Insurance.
Medical, Dental & Vision insurances
FSA, DCARE, Commuter Benefits
Supplemental Life, Hospital, Critical Illness and Legal Insurance
Health Savings Account
401(k) Retirement Plan (Employer Matching benefit)
Paid Time Off (Rollover Option) and Holidays
As Needed Sick Time
Tuition Reimbursement
Team Social Activities (We have fun!)
Employee Recognition
Employee Referral Program
Paid Parental Leave and Bereavement

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For more information about our company, please visit us at Verista.com