Cleaning Validation Engineer

PSC Biotech • Minneapolis, MN

19h • Onsite

About The Position

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.

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.
• Must be authorized to work in the U.S.
• No C2C at this time.

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.
• Coordinate sampling activities and ensure adherence to approved protocols and site procedures.
• Support investigation and resolution of protocol discrepancies, deviations, and documentation issues.
• Maintain complete and accurate validation documentation in accordance with GMP requirements and client procedures.
• 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.

Benefits

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
• 401(k) and 401(k) matching
• PTO, Sick Time, and Paid Holidays
• Education Assistance
• Pet Insurance
• Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)
• Financial Perks and Discounts

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level