Verista, Inc.

Verista, Inc.

6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2

Durham, NC · Senior

Sponsorship not specified$65k-$91kDetected 47 days ago
PLCGMP

About the role

  • Familiarity with global standards for computerized systems and data integrity.
  • Ability to classify systems as "simple" or "complex" using risk‑based criteria to right‑size validation effort.
  • Experience authoring CSV deliverables: URS/FDS/DDS review, risk assessments, test protocols (IQ/OQ), and summary reports.

Responsibilities

  • Develop data flow diagrams for critical integrations:
  • Document any deviations discovered during CSV testing, perform impact assessment, and track CAPAs to closure.

Requirements

  • Bachelor's degree in engineering, computer science, or related field.
  • Minimum 5 years of CSV experience in GMP pharmaceutical or biotech environments.
  • Proven experience with equipment‑level PLC/HMI validation (OEM systems) and historian connectivity.
  • Must be local in or around RTP, must be able to work on site 100%.

Nice to have

  • Hands‑on experience with PAT instrument integration (e.g., NIR, moisture analyzers) is a strong plus.
  • Competitive pay plus performance-based incentive programs

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.