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5608- CSV Engineer / Validation Engineer

Baton Rouge, LA (Remote)

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

  • 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

We are seeking a detail-oriented and experienced CSV Validation Engineer to support the validation of a DocuSign application in compliance with regulatory standards (e.g., FDA 21 CFR Part 11, GAMP 5). The successful candidate will be responsible for ensuring the system meets quality, security, and compliance requirements through the development, execution, and documentation of validation protocols.

CSV Engineer Responsibilities:

  • Develop and execute validation deliverables, including Validation Plans, User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Risk Assessments, Test Protocols (IQ/OQ/PQ), and Validation Summary Reports specific to the COTS version of the DocuSign application
  • Perform risk-based validation assessments to ensure compliance with regulatory and industry standards for electronic signatures and records
  • Collaborate with cross-functional teams (IT, QA, and business stakeholders) to define system requirements and ensure alignment with business processes
  • Conduct testing, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), to verify system functionality, security, and data integrity
  • Identify document, and resolve deviations or discrepancies encountered during validation activities
  • Ensure traceability of requirements throughout the validation lifecycle using a traceability matrix
  • Maintain validation documentation in accordance with Good Documentation Practices (GDP)

 

Requirements:

  • Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field
  • 5+ years of experience in computer system validation (CSV) within a regulated industry (pharmaceutical, biotech, or medical device preferred)
  • Hands-on experience validating cloud-based SaaS applications, with specific knowledge of DocuSign required
  • Strong understanding of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity principles
  • Proficiency in writing and executing validation protocols (IQ/OQ/PQ) and related documentation
  • Excellent problem-solving skills and attention to detail
  • Ability to work independently and collaboratively in a team environment
  • Familiarity with tools such as Jira, Confluence, or ALM systems is a plus

 

 

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

$80,465 - $127,000 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

Verista collects and processes personal data in accordance with applicable data protection laws.  If you are a California Job Applicant, see the privacy notice for further details. 

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

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