Verista

6487 - Veeva LIMS SME Consultant / Lead Information Systems Engineer

Verista • $85K — $136K *
Indianapolis, IN 46227In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Reposted Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical discipline
  • 5+ years of experience in computerized system validation within regulated environments
  • Demonstrated experience with Veeva LIMS implementation and validation
  • Strong understanding of CSV/CSA methodologies, GxP requirements, and data integrity
  • Experience developing validation documentation and executing test protocols
  • Familiarity with 21 CFR Part 11, EU Annex 11, and GAMP 5 standards
  • Strong communication, project management, and problem-solving skills

Responsibilities

  • Lead Veeva LIMS implementation and manage validation activities through the system lifecycle
  • Develop and review critical validation deliverables like validation plans and test scripts
  • Collaborate with various teams to define system requirements and ensure compliance
  • Conduct functional and integration testing of the Veeva LIMS
  • Apply risk-based validation principles to maintain system integrity
  • Oversee data migration and system integration during LIMS rollout
  • Engage in quality assurance activities, including change control and audit readiness

Benefits

  • High growth potential in a fast-paced, people-focused culture
  • Performance-based incentive programs
  • Company-paid life and disability insurance
  • Comprehensive medical, dental, and vision insurance
  • Flexible spending accounts and commuter benefits
  • 401(k) retirement plan with employer matching
  • Paid time off with rollover option and holidays
  • Tuition reimbursement and team social activities
  • Paid parental leave and bereavement support
Full Job Description
Lead IS Engineer Responsibilities:
  • 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

Job Requirements:
  • 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.

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

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

About Verista

Verista is a software company that provides a platform for managing and automating business processes. The company's platform uses artificial intelligence and machine learning to analyze data and optimize workflows. Verista's customers include companies in the healthcare, financial services, and manufacturing industries. The company was founded in 2017 and is headquartered in Palo Alto, California.
Learn more about Verista
Size
50 employees
Industry
Enterprise Technology
Founded
2017
* Ladders Estimates

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