Senior CQV Engineer: Lead Life-Science Validation

Verista

Wichita (KS)

On-site

USD 79,000 - 123,000

Full time

8 hours ago
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Benefits offered by this job

Life Insurance
Medical, Dental & Vision insurances
401(k) Retirement Plan (Employer Match
Paid Time Off
Tuition Reimbursement
Employee Referral Program
Parental Leave
Bereavement leave

Job summary

Verista is seeking a Senior Validation Engineer to lead CQV activities for facilities, utilities, and equipment in GxP environments. You will author and execute IQ/OQ/PQ protocols, manage deviations, and coordinate with engineering, quality, and vendors to ensure project readiness and regulatory compliance.

You will mentor junior CQV engineers, develop standardized CQV processes, and ensure all deliverables meet GDP and data integrity standards across multiple concurrent projects.

Qualifications

  • Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
  • 5+ years of hands-on CQV experience within regulated life sciences environments.
  • Experience authoring and executing CQV/qualification documentation.
  • Strong experience with IQ/OQ/PQ protocols and commissioning documentation.
  • Experience with facilities, utilities, equipment, lab systems, or computerized systems.
  • Solid understanding of cGMP and qualification lifecycle; deviation/change control.
  • Proven written and verbal communication, organizational, and problem‑solving skills.
  • Experience leading CQV activities on large pharma/biotech capital projects.

Responsibilities

  • Lead and/or support CQV activities for facilities, utilities, equipment, lab systems, and computerized systems in GxP environments.
  • Author, review, and execute CQV documentation including URS, risk assessments, protocols and reports.
  • Develop and execute IQ/OQ/PQ testing, walkdowns, field verifications, punch-lists, and acceptance testing.
  • Coordinate on-site execution, ensure protocols followed, document results, and resolve discrepancies.
  • Collaborate with Engineering, Quality, Operations, and vendors to schedule testing and deliverables.
  • Review drawings, specs, manuals, and test records to support CQV planning and execution.
  • Ensure CQV activities comply with GDP, data integrity, and regulatory requirements.
  • Manage deviations, changes, and corrective actions related to CQV tasks.
  • Provide mentorship to junior CQV engineers and help standardize CQV processes.

Skills

CQV execution
GxP compliance
IQ/OQ/PQ protocols
Technical writing
Vendor coordination
Regulatory knowledge
Data integrity ALCOA+
Leadership mentorship

Education

Bachelor’s degree in Engineering or Life Sciences

Job description

Verista is seeking a Senior Validation Engineer to lead CQV activities for facilities, utilities, and equipment in GxP environments. You will author and execute IQ/OQ/PQ protocols, manage deviations, and coordinate with engineering, quality, and vendors to ensure project readiness and regulatory compliance.

You will mentor junior CQV engineers, develop standardized CQV processes, and ensure all deliverables meet GDP and data integrity standards across multiple concurrent projects.

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