CQV Engineer

Concord, NC, US • Posted 1 day ago • Updated 2 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

⭐ Evaluating experience...

Job Details

Skills

  • Life Sciences
  • Manufacturing
  • GMP
  • Risk Assessment
  • Corrective And Preventive Action
  • Change Control
  • Documentation
  • Regulatory Compliance
  • Pharmaceutics
  • IQ
  • OQ
  • PQ
  • Good Manufacturing Practice
  • GAMP
  • SIP

Summary

Summary :
Seeking a CQV Validation Engineer experience in pharmaceutical, biotech, or life sciences. The ideal candidate will have hands-on experience with Commissioning, Qualification & Validation (CQV) for standalone manufacturing equipment in a GMP-regulated environment.

Roles & Responsibilities :
  • Perform CQV activities for standalone equipment.
  • Author and execute IQ/OQ/PQ protocols, validation plans, and reports.
  • Support FAT, SAT, commissioning, qualification, and validation activities.
  • Perform risk assessments and support deviations, CAPA, and change control.
  • Review vendor documentation, equipment manuals, and engineering drawings.
  • Ensure compliance with FDA, cGMP, GAMP 5, and 21 CFR Part 11.

Education & Experience :
  • 5+ years of CQV validation experience in Pharma/Biotech.
  • Strong experience with standalone equipment qualification.
  • Hands-on experience with IQ/OQ/PQ protocol authoring and execution.
  • Knowledge of FDA, cGMP, GAMP 5, ISPE, and 21 CFR Part 11.
  • Preferred Equipment
  • Autoclaves, Washers, Bioreactors, Mixers, Tanks & Vessels, CIP/SIP Systems, Process Skids, Filling Equipment, Packaging Equipment, Incubators, and Freezers.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: c0c46b47a8c8cc8e73c85b509b3d626b
  • Posted 1 day ago
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