Cleaning Validation Engineer

About the role

The Cleaning Validation Engineer supports biopharmaceutical manufacturing operations by developing, modifying, executing, and reporting cleaning validation activities. This role focuses on cleaning validation for production equipment, including harvest centrifuges and production bioreactors.

Responsibilities

• Develop, modify, execute, and manage cleaning validation protocols for harvest centrifuges, production bioreactors, and associated manufacturing equipment.
• Generate cleaning validation reports, ensuring accurate documentation of execution results and conclusions.
• Author, execute, review, and route validation protocols within Kneat.
• Perform on-site protocol execution activities, including swab and rinse sampling.
• Collaborate with Quality, Manufacturing, Engineering, and Validation teams to support project timelines and deliverables.
• Ensure compliance with established cleaning validation strategies, acceptance criteria, and quality systems.
• Complete all required site training and adhere to site-specific safety, quality, and operational standards.

Requirements

• Bachelor's degree in Engineering, Biology, Chemistry, Life Sciences, or a related technical discipline.
• 3+ years of experience in Cleaning Validation, CQV, Validation, or Quality Engineering within the pharmaceutical, biotechnology, or life sciences industry.
• Hands-on experience developing, modifying, and executing cleaning validation protocols.
• Experience performing swab and rinse sampling activities in a GMP manufacturing environment.
• Experience with cleaning validation of centrifuges, bioreactors, CIP systems, and process equipment.
• Experience generating and reviewing validation reports and supporting documentation.
• Strong understanding of GMP regulations, validation lifecycle principles, and documentation practices.
• Kneat experience is required, including protocol authoring, execution, review, and routing.
• Ability to work on-site and support execution activities in manufacturing environments.
• Strong technical writing, communication, and organizational skills.

Qualifications

Must be authorized to work in the U.S.

Skills

None specified

Benefits

Medical, Dental, and Vision insurance, 401(k) and 401(k) matching, PTO, Sick Time, and Paid Holidays, Education Assistance, Pet Insurance, Fitness Benefits, Financial Perks and Discounts, Salary range: $90,000 - $105,000 annually.

Pay

$90,000 - $105,000 annually

Schedule

N/A