CQV / CLEANING VALIDATION ENGINEER

Weil Group, Inc; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Weil Group, Inc. is seeking a CQV/Cleaning Validation Engineer to develop and execute Cleaning Characterization and Cleaning Verification for manufacturing equipment and process systems in a pharmaceutical setting.

The role requires strong validation experience, proficiency in TOC and microbiological testing, and ability to coordinate sampling and reports. You will review procedures, equipment drawings, and process recipes, perform field verifications, and support validation activities across

Qualifications

• Minimum B.S. in engineering or life sciences with pharma background.
• At least 5 years in pharmaceutical CQV/validation environments.
• At least 3 years in Cleaning Validation or Cleaning Verification.
• Familiarity with CIP systems, cleaning cycles, TOC and microbiology testing.

Responsibilities

• Develop Cleaning Characterization and Cleaning Verification docs and field activities.
• Prepare characterization protocols and final reports for cleaning processes.
• Review procedures, batch records, P&IDs, and process recipes for validation readiness.
• Coordinate sampling plans for TOC and microbiological surface testing.
• Perform or support swab sampling and sample collection per protocol.
• Review data against acceptance criteria and document discrepancies.
• Provide execution support during off-shifts or extended hours as needed.

Skills

CQV/Cleaning Validation experience

Pharmaceutical manufacturing knowledge

Documentation/Report writing

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Chemistry, Microbiology, Biotechnology, Life Sciences, or related discipline

Tools

TOC analysis tools

PI Historian

Job description

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.*