Cleaning Validation Engineer

Job Title: Cleaning Validation Engineer
Location: Worcester County, MA Onsite
Duration: 12 Months
Employment Type: W2 Contract

Summary

Seeking a Cleaning Validation Engineer with 5+ years of hands-on experience in pharmaceutical or biotech manufacturing. The ideal candidate should have strong knowledge of cleaning validation, CIP, COP, manual cleaning, and cGMP requirements.

• Manage cleaning validation and verification activities.

• Prepare and execute validation protocols, reports, and risk assessments.

• Support CIP, COP, and manual cleaning processes.

• Develop and improve cleaning processes for manufacturing equipment.

• Investigate cleaning deviations, OOS results, and related issues.

• Support Dirty Hold Time (DHT) and Clean Hold Time (CHT) studies.

• Maintain cleaning processes in a validated state through ongoing verification.

• Partner with QA, QC, Engineering, Manufacturing, and Operations teams.

• Ensure cleaning activities meet cGMP and regulatory requirements.

• Bachelor's/Master's degree in Life Sciences, Pharmacy, Chemistry, Biology, Chemical Engineering, or related field.

• 5+ years of direct cleaning validation experience in pharma or biotech.

• Hands-on experience with CIP, COP, and manual cleaning.

• Strong understanding of cleaning validation and cGMP requirements.

• Experience with validation protocols, risk assessments, DOE, and technical documentation.

• Experience handling deviations, OOS investigations, and root-cause analysis.

• Knowledge of ASTM E2500.

• Sterile/aseptic manufacturing experience is a plus.