Cleaning Validation Engineer – Biopharmaceutical Manufacturing

Job Summary:

Seeking a hands-on Cleaning Validation Engineer with pharmaceutical or biopharmaceutical experience to execute cleaning validation protocols for manufacturing equipment. The ideal candidate must have a strong understanding of Total Organic Carbon (TOC) acceptance criteria and calculations, including how limits are derived from MACO, ADE/PDE, batch size, and relevant equipment and sampling parameters.

Equipment and Cleaning Agents

• Cytiva TFF and chromatography process skids: Sodium hydroxide (NaOH) and Water for Injection (WFI).
• Stainless steel vessels: CIP100/CIP200 and WFI.

Key Responsibilities:

• Prepare, review, and execute cleaning validation protocols for process skids and stainless steel vessels.
• Establish, calculate, and justify cleaning acceptance limits, including TOC limits, using Maximum Allowable Carryover (MACO), Acceptable Daily Exposure (ADE), Permitted Daily Exposure (PDE), batch size, and applicable process parameters.
• Translate established residue limits into appropriate rinse and swab sampling acceptance criteria.
• Perform or coordinate sampling, review analytical results, and assess compliance with protocol acceptance criteria.
• Evaluate cleaning effectiveness for the specified equipment and cleaning agents.
• Document execution results, investigate deviations or failures, and prepare cleaning validation reports.
• Work closely with Manufacturing, Quality Assurance, QC, and Engineering to complete validation activities in accordance with approved procedures and GMP requirements.

Required Qualifications:

• 5+ years of relevant cleaning validation experience in pharmaceutical or biopharmaceutical manufacturing.
• Demonstrated hands-on experience running and executing cleaning validation protocols.
• Strong understanding of TOC acceptance criteria and calculations based on MACO, ADE/PDE, batch size, equipment surface area, sampling volume, and recovery factors, as applicable.
• Experience with TFF/chromatography process skids and stainless steel vessels.
• Familiarity with NaOH, CIP100/CIP200, and WFI cleaning processes.
• Experience with rinse/swab sampling, analytical data review, deviations, and validation documentation.
• Strong knowledge of GMP practices and attention to accurate, complete documentation.

Benefits:

Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

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.