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Validation Engineer 2

2 months ago


Indianapolis Indiana, United States Verista Full time
About the Role

As a Validation Engineer 2 at Verista, you will play a critical role in empowering growth and innovation within the scientific community. You will work closely with our team of experts to solve complex healthcare challenges and enable life sciences clients to improve lives.

Key Responsibilities
  • Independently understand client quality standards, cGMPs, and regulatory standards to support the team in compliance with validation efforts.
  • Verify testing against specifications and manage collaborative work with clients' quality representatives to complete deviation investigations and resolutions.
  • Support clients' change management programs, including authoring proposed changes, executing impact assessments, and supporting client documentation.
  • Author, edit, and execute technical commissioning, qualification, and validation documentation for standard equipment, systems, software, and processes.
  • Run test scripts, document results, and maintain clear, detailed records of qualification and validation.
  • Develop, review, and execute testing documentation, making recommendations for design or process modifications based on test results.
  • Read technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment.
  • Understand validation documents, URS, IQ, OQ, and PQ, and verify system drawings, including review and as-built P&IDs and I&C drawings.
Requirements
  • Bachelor's Degree or equivalent required.
  • 2-4 years of applicable industry experience.
  • Proficiency using PC and Microsoft Office tools.
  • Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.
  • Ability to work as part of a team.
  • Strong problem-solving and critical thinking skills.
  • Excellent organizational and time management skills.
  • Strong attention to detail.
  • GMP and Good Documentation Practice training (may be completed at onboarding).
  • Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes).
  • Basic skills with EXCEL and PowerPoint.
  • Strong interpersonal skills and clear communication capabilities.
About Verista

Verista is a high-growth organization with a people-focused culture. We offer competitive pay, performance-based incentive programs, and a comprehensive benefits package, including company-paid life, short-term, and long-term disability insurance, medical, dental, and vision insurance, FSA, DCARE, commuter benefits, supplemental life, hospital, critical illness, and legal insurance, health savings account, 401(k) retirement plan, paid time off, holidays, as-needed sick time, tuition reimbursement, team social activities, employee recognition, employee referral program, paid parental leave, and bereavement leave.