Verista

6487 - Veeva LIMS SME Consultant / Senior Validation Engineer

Verista • $85K — $136K *
Indianapolis, IN 46227In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
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
Senior Validation Engineer 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

Job 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


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

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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