Cleaning Validation Engineer (Pharmaceutical)

TL;DR

Cleaning Validation Engineer (Pharmaceutical): Developing, executing, and reporting on cleaning validation for biopharmaceutical manufacturing equipment with an accent on GMP compliance and documentation. Focus on authoring protocols in Kneat, performing on-site sampling for centrifuges and bioreactors, and ensuring adherence to quality standards.

Location: Minneapolis, United States. Must be authorized to work in the U.S.

Salary: $90,000 - $105,000 annually

Company

hirify.global provides the life sciences industry with essential services to ensure healthcare products are developed and manufactured in compliance with regulatory requirements.

What you will do

• Develop and execute cleaning validation protocols for harvest centrifuges, bioreactors, and associated manufacturing equipment.
• Generate detailed cleaning validation reports, ensuring accurate documentation of results and conclusions.
• Author, execute, review, and route validation protocols using the Kneat system.
• Perform on-site sampling activities, including swab and rinse sampling in manufacturing environments.
• Investigate and resolve protocol discrepancies, deviations, and documentation issues.
• Collaborate with Quality, Manufacturing, and Engineering teams to meet project timelines and deliverables.

Requirements

• Bachelor's degree in Engineering, Biology, Chemistry, Life Sciences, or a related technical field.
• 3+ years of experience in Cleaning Validation, CQV, or Quality Engineering within the pharma, biotech, or life sciences industry.
• Hands-on experience with swab and rinse sampling in a GMP manufacturing environment.
• Experience validating centrifuges, bioreactors, and CIP systems.
• Required experience with Kneat (authoring, execution, review, and routing).
• Must be authorized to work in the United States (No C2C).

Culture & Benefits

• Comprehensive health coverage: 100% of employee medical premiums and 50% for qualifying dependents.
• 401(k) plan with company matching.
• Paid Time Off (PTO), sick time, and paid holidays.
• Education assistance and financial perks/discounts.
• Additional benefits including pet insurance and fitness membership discounts.