:Cleaning Validation Engineer

Cleaning Validation Engineer

Location: Worcester County, MA
Duration: 12 Months
Rate: $55/hr $60/hr on W2

Job Summary

Seeking an experienced Cleaning Validation Engineer to lead and support cleaning validation, verification, and process development activities in a pharmaceutical/biotech manufacturing environment.

Key Responsibilities

• Develop, execute, and maintain cleaning validation and verification programs.

• Support CIP, COP, and manual cleaning processes.

• Develop validation protocols, risk assessments, sampling plans, and technical reports.

• Perform cleaning process design, DOE, troubleshooting, and root-cause investigations.

• Establish Dirty Hold Time (DHT) and Clean Hold Time (CHT).

• Support NPI, technical transfer, process improvement, and equipment qualification.

• Ensure compliance with cGMP, US/EU regulations, ASTM E2500, and site quality standards.

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

• Maintain validated status and support continued process verification (CPV).

Required Qualifications

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

• 5+ years of hands-on Cleaning Validation experience in pharmaceutical/biotech manufacturing.

• Strong experience with CIP, COP, and manual cleaning.

• Experience with risk assessments, DOE, analytical methods, recovery studies, and validation protocols.

• Knowledge of sterile/aseptic and CDMO operations.

• Strong technical writing, problem-solving, and project leadership skills.

• Experience with ASTM E2500 and cGMP regulatory requirements.

Benefits: This a contract position does not include employer-provided benefits.

Equal Opportunity Employer:
We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to
race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background Check:
Background checks may be conducted in accordance with applicable law.

Work Authorization:
Applicants must be authorized to work in the United States