CQV Validation Engineer II — Drive GMP Compliance

Verista, Inc.

Vista (CA)

On-site

USD 74,000 - 118,000

Full time

7 days ago
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Benefits offered by this job

Competitive pay
401(k) Retirement Plan
Paid Time Off
Medical, Dental & Vision
Tuition Reimbursement

Job summary

Verista is seeking a CQV Engineer with a strong background in validation within regulated life sciences manufacturing. The role focuses on reviewing validation documentation for accuracy, completeness, and regulatory compliance across GMP environments.

A minimum of 3 years of CQV experience and hands-on work with manufacturing systems is preferred. The successful candidate will collaborate with Engineering, Quality, Validation, and Operations to resolve discrepancies, ensure GDP adherence, and

Qualifications

  • 3+ years of validation/CQV experience in regulated pharma/biotech manufacturing.
  • Bachelor’s degree in engineering, life sciences or related field preferred.
  • Strong understanding of validation lifecycle (IQ/OQ/PQ) and GDP/Good Documentation Practices.

Responsibilities

  • Review commissioning, qualification, and validation documentation for accuracy, completeness, and compliance.
  • Review protocols, test scripts, reports, deviations, and supporting validation documentation.
  • Verify qualification activities meet procedures, specs, acceptance criteria, and GMP requirements.
  • Apply understanding of the validation lifecycle (IQ/OQ/PQ) and closeout processes.
  • Review documentation for process equipment (tanks, reactors, vessels, etc.).
  • Identify gaps, discrepancies, and compliance concerns; collaborate with Engineering, Validation, Quality, and Operations to resolve.
  • Ensure validation records are inspection/audit ready and GDP-compliant.
  • Support validation and qualification activities as needed.

Skills

Validation experience
Cross-functional collaboration
Attention to detail
GMP knowledge
Documentation review

Education

Bachelor's degree in Engineering, Life Sciences, or related discipline

Job description

Verista is seeking a CQV Engineer with a strong background in validation within regulated life sciences manufacturing. The role focuses on reviewing validation documentation for accuracy, completeness, and regulatory compliance across GMP environments.

A minimum of 3 years of CQV experience and hands-on work with manufacturing systems is preferred. The successful candidate will collaborate with Engineering, Quality, Validation, and Operations to resolve discrepancies, ensure GDP adherence, and

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