Job DescriptionThe 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.
BenefitsOffering 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.
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