CQV Validation Engineer for Life Sciences

Pinnaql

Cincinnati (OH)

On-site

USD 85,000 - 120,000

Full time

4 days ago
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Job summary

Pinnaql is seeking a Validation Engineer with CQV experience to lead commissioning, qualification, and validation activities for regulated life sciences facilities and equipment. You will develop and review IQ/OQ/PQ protocols, risk assessments, and validation reports while ensuring GMP and FDA/EU compliance.

Collaboration with engineering, QA, manufacturing, and automation teams is essential. The role emphasizes strong technical writing, attention to detail, and the ability to manage validation

Qualifications

  • Bachelor’s degree in Engineering, Science, or a related technical discipline.
  • 3 years of validation, qualification, commissioning, or CQV experience in a regulated life sciences environment.
  • Experience in GMP-regulated industries (pharma, biotech, medical device).
  • Strong technical writing and documentation skills; ability to interpret engineering drawings and specifications.

Responsibilities

  • Execute and support CQV activities for regulated life sciences facilities and equipment.
  • Develop, review, and execute validation documentation (IQ/OQ/PQ, risk assessments, protocols, reports).
  • Support qualification of equipment, facilities, utilities, and manufacturing systems.
  • Ensure validation activities comply with GMP, FDA, EU GMP, and industry standards.
  • Collaborate with Engineering, QA, Manufacturing, and Automation; track deliverables and milestones.

Skills

CQV experience
Technical writing
Project management
Independent work
Cross-functional collaboration

Education

Bachelor’s degree in Engineering, Science, or related technical discipline

Tools

IQ/OQ/PQ protocols

Job description

Pinnaql is seeking a Validation Engineer with CQV experience to lead commissioning, qualification, and validation activities for regulated life sciences facilities and equipment. You will develop and review IQ/OQ/PQ protocols, risk assessments, and validation reports while ensuring GMP and FDA/EU compliance.

Collaboration with engineering, QA, manufacturing, and automation teams is essential. The role emphasizes strong technical writing, attention to detail, and the ability to manage validation

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