Cleaning Validation Engineer

PSC Biotech; Minneapolis (MN); On-site; USD 90,000 - 105,000; Full time

Benefits offered by this job

Medical, Dental, and Vision coverage

401(k) and matching

Paid holidays and PTO

Education Assistance

Pet Insurance

Fitness benefits

Job summary

PSC Biotech is seeking a Cleaning Validation Engineer to support biopharmaceutical manufacturing by developing, modifying, executing, and reporting cleaning validation protocols for harvest centrifuges, production bioreactors, and related equipment.

The role ensures GMP compliance, authoring and reviewing Kneat protocols, performing on-site sampling, and coordinating cross-functional validation activities with Quality, Manufacturing, Engineering, and Validation teams.

Qualifications

• 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.
• Hands-on experience developing, modifying, and executing cleaning validation protocols.
• Experience with swab and rinse sampling activities in a GMP manufacturing environment.
• Kneat experience is required, including protocol authoring, execution, review, and routing.
• Ability to work on-site and support execution activities in manufacturing environments.

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.

Skills

Technical writing

Communication

Organizational skills

On-site work

Education

Bachelor's degree in Engineering, Biology, Chemistry, Life Sciences, or related technical discipline

Tools

Kneat

Job description

Minneapolis, United States

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.

Your Role

The Cleaning Validation Engineer is responsible for the development, modification, execution, and reporting of cleaning validation activities supporting biopharmaceutical manufacturing operations. This role will focus on cleaning validation for production equipment, including harvest centrifuges and production bioreactors, ensuring compliance with GMP requirements and client quality standards. The engineer will author, execute, and route validation protocols within Kneat, perform on-site sampling activities, and support the successful completion of cleaning validation deliverables.

• 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.
  

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.
  

Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.

• 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

The salary bracket for this role is set between $90,000 - $105,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.

Equal Opportunity Employment Statement

PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.