Position Summary
The CQV/Cleaning Validation Engineer will develop and execute Cleaning Characterization and Cleaning Verification documentation and field activities for manufacturing equipment and process systems.

Key Responsibilities
• Prepare Cleaning Characterization protocols and final reports.
• Review applicable manufacturing procedures, batch records, equipment drawings, P&IDs, isometrics, and process recipes.
• Review equipment sequence of operations and cleaning cycles.
• Evaluate CIP/SIP circuits as applicable.
• Perform product contact surface area calculations.
• Perform field verification of equipment dimensions and product contact surfaces when information is not available or needs to be confirmed.
• Prepare sampling plans for TOC and microbiological surface sampling.
• Perform or support swab sampling and other sample collection activities required by the protocol.
• Coordinate sample labeling, custody, and delivery to the QC laboratory.
• Participate in Engineering Runs, Pre-PPQ, PPQ, changeover, and Release for Use activities, as required.
• Review process data and results against established acceptance criteria.
• Generate and review PI Historian trends, as applicable.
• Document discrepancies and support related investigation activities.
• Prepare final reports within the established project timelines.
• Perform peer review of calculations, data, and execution results when required.
• Provide execution support during off-shifts, weekends, or extended hours based on project needs.

Minimum Recommended Qualifications
• Bachelor's degree in Engineering, Chemistry, Microbiology, Biotechnology, Life Sciences, or related discipline.
• Minimum 5 years of pharmaceutical/biotechnology CQV or validation experience.
• Minimum 3 years of Cleaning Validation or Cleaning Verification experience.
• Knowledge of CIP systems, cleaning cycles, sampling strategies, TOC, and microbiological testing.