6487 - Veeva LIMS SME Consultant / Lead Information Systems Engineer

United States·Indianapolissenior

OtherQA & TestingValidation EngineerSystems

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Quick Summary

Key Responsibilities

Lead and/or support Veeva LIMS implementation activities from

Technical Tools

OtherQA & TestingValidation EngineerSystems

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

~2 min read

→Lead and/or support Veeva LIMS implementation activities from requirements gathering and process design through configuration, integration, testing, deployment, and go-live
→Partner with Laboratory, Quality, IT, Business Process Owners, and other stakeholders to define business requirements, map laboratory workflows, and translate business needs into effective LIMS solutions
→Support Veeva LIMS configuration and system design, including workflows, user roles, master data, specifications, calculations, reporting, and other system functionality.
→Coordinate and support system integrations, interfaces, and data migration activities to ensure successful connectivity with instruments, enterprise applications, and related laboratory systems
→Lead or support functional testing, integration testing, user acceptance testing (UAT), defect management, and issue resolution throughout the implementation lifecycle.
→Facilitate implementation workshops, requirements reviews, design sessions, testing activities, and stakeholder meetings; coordinate actions and drive issues to resolution
→Support deployment, cutover, go-live, and post-implementation stabilization, including troubleshooting, user support, and transition to ongoing system ownership
→Develop and/or review implementation and supporting documentation, including requirements, functional specifications, configuration documentation, test plans/scripts, traceability, SOPs, and implementation/transition documentation
→Apply risk-based CSV/CSA and GxP principles throughout the implementation to ensure the system is appropriately assessed, tested, and fit for intended use
→Support system lifecycle activities following implementation, including change control, enhancements, defect resolution, periodic reviews, and continuous improvement
→Ensure the implementation addresses applicable regulatory and data integrity expectations, including 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ principles
→Provide technical subject matter expertise and serve as a key liaison between business users, laboratory teams, IT, Quality, vendors, and implementation partners

Requirements

~2 min read

Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related technical discipline
5+ years of experience supporting LIMS implementations, system implementations, laboratory systems, or related technology projects within pharmaceutical, biotechnology, or other GxP-regulated environments
Demonstrated experience with Veeva LIMS implementation, validation, or lifecycle management
Experience with Veeva LIMS or other enterprise LIMS platforms such as LabWare, LabVantage, or similar systems
Demonstrated ability to translate laboratory/business requirements into system functionality, including workflow, configuration, integration, and reporting requirements
Experience coordinating system integrations, interfaces, data migration, UAT, defect management, deployment, and post-go-live support
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