Cleaning Validation Engineer

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. Benefits Equal Opportunity Employment Statement PSC 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. #LI-DC1