Job Title:

Cleaning Validation Engineer Location:

Milford, MA Employment Type:

W2

Contract Experience Required:

5+ years

Pay Rate:

$45-50/hour on W2 Job Summary We are seeking an experienced Cleaning Validation Engineer with a strong understanding of cleaning validation principles, Total Organic Carbon (TOC) acceptance criteria, and residue limit calculations. The ideal candidate will have hands-on experience executing cleaning validation (CV) protocols for biopharmaceutical manufacturing equipment, including tangential flow filtration (TFF) and chromatography process skids, as well as stainless steel vessels. Key Responsibilities Execute and run cleaning validation protocols for biopharmaceutical manufacturing equipment. Establish and evaluate TOC acceptance criteria based on Maximum Allowable Carryover (MACO), Acceptable Daily Exposure (ADE), Permitted Daily Exposure (PDE), and batch size. Support cleaning validation activities for Cytiva-manufactured TFF and chromatography process skids using sodium hydroxide (NaOH) and Water for Injection (WFI) as cleaning agents. Execute cleaning validation activities for stainless steel vessels utilizing

CIP 100/CIP 200

cleaning agents and WFI. Evaluate cleaning effectiveness and verify compliance with established acceptance criteria. Review cleaning validation results and supporting documentation to ensure adherence to applicable quality and validation requirements. Required Qualifications 5+ years of relevant cleaning validation experience. Strong understanding of TOC acceptance criteria and calculations based on MACO, ADE, PDE, and batch size. Hands-on experience running and executing cleaning validation protocols. Experience with biopharmaceutical manufacturing equipment, including process skids and stainless-steel vessels. Familiarity with NaOH, WFI, CIP 100, and CIP 200 cleaning agents.

Education Preference :

Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, Pharmaceutical Sciences, or a related life sciences or engineering discipline. Benefits Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance:

Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits:

A 401(k)-retirement savings plan is available. No employer matching or other employer contributions are provided. Paid Time Off (PTO): No PTO other than that required by applicable state and local laws

Equal Employment Opportunity:

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law. Application Interested candidates with relevant hands-on cleaning validation experience are encouraged to apply.

Pay:

$45.00 - $50.00 per hour Expected hours: 40.0 per week

Benefits:

401(k) Retirement plan

Work Location:

In person