Verista, Inc.

Verista, Inc.

6321 - Validation Engineer / CQV Engineer - Change Control & Deviations

Indianapolis, IN

Sponsorship not specified$60k-$103kDetected 15 hours ago
ControlsGMPMedical DevicesCommunicationCollaborationWriting

About the role

  • 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 talented and dedicated professionals are committed to making an impact every day.
  • This role will play a critical part in maintaining compliance, supporting quality systems, and ensuring manufacturing changes are properly assessed, documented, and executed in a regulated cGMP environment.

Responsibilities

  • Author, review, and manage change controls impacting systems, equipment, and processes
  • Perform impact assessments, including evaluation of product quality, validated state, and regulatory impact
  • Collaborate with cross-functional teams (Engineering, Quality, Validation, Manufacturing) to ensure timely and compliant change implementation
  • Support execution of change control deliverables, including updates to validation documentation (IQ/OQ/PQ, protocols, reports)
  • Lead and support deviation investigations, including root cause analysis and corrective/preventive actions (CAPAs)
  • Partner with Quality teams to ensure compliance with internal procedures and regulatory expectations
  • Maintain alignment with cGMP and Good Documentation Practices (GDP)
  • Support validation impact assessments and execution activities related to changes
  • Participate in audits and inspections, providing SME support for change control and deviation processes
  • Support continuous improvement initiatives related to quality systems and CQV processes

Requirements

  • Bachelor's degree in Engineering, Life Sciences, or related field
  • 1-3 years of experience in CQV, Validation, or Quality Engineering in a regulated industry
  • Strong experience with:

Nice to have

  • Familiarity with device assembly/packaging operations is highly preferred
  • Experience supporting validation lifecycle activities (IQ/OQ/PQ) is a plus

Compensation

  • For US geography, the salary range for this position is shown below.

Benefits

  • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • Tuition Reimbursement
  • Paid Parental Leave and Bereavement

Company info

  • 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
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This listing is sourced directly from Verista, Inc.'s careers page and normalized into a canonical job model.