CQV / CLEANING VALIDATION ENGINEER

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.

*Weil Group is proud to be an Equal Employment Opportunity Employer.*