Cleaning Validation Engineer - Program DevelopmentZachary Piper Solutions • Cary, NC, US
Cleaning Validation Engineer - Program Development
Zachary Piper Solutions • Cary, NC, US
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job_description.job_card.job_descriptionAuthor and review cleaning validation protocols, risk assessments, and final reports. Collaborate with cross-functional teams including Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs. Support equipment commissioning and qualification efforts related to cleaning processes. Investigate and resolve cleaning validation deviations and non-conformances. Maintain and improve cleaning validation lifecycle documentation and procedures. Bachelor’s or Master’s degree in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or a related field. 5+ years of experience in cleaning validation within the pharmaceutical or biopharmaceutical industry. Proven experience developing and executing cleaning validation programs from scratch. Strong understanding of regulatory guidelines (FDA, EMA, ICH, etc.) and industry best practices. Experience with isolator technology and aseptic processing environments is highly desirable. Excellent technical writing, communication, and project management skills. $75 - $85 / hour Company-Subsidized Benefits : Medical, Dental, Vision, 401K-with match, PTO, Sick Leave as required by law, and Holidays
Company Profile
Join a global leader in biopharmaceutical contract development and manufacturing (CDMO), renowned for innovation, scale, and a commitment to quality. As we continue to expand our capabilities and facilities, we are seeking a Cleaning Validation Engineer to lead the development and implementation of a world-class cleaning validation program.
Assignment Profile
As a Cleaning Validation Engineer , you will be responsible for designing, developing, and executing a comprehensive cleaning validation program from the ground up. This includes cleaning validation strategies for parts washers, factory components, and isolator filling lines. You will play a critical role in ensuring compliance with global regulatory standards and supporting the launch of new manufacturing capabilities.
Key Responsibilities
- Develop and implement a robust cleaning validation program aligned with cGMP, FDA, EMA, and other global regulatory requirements.
- Lead cleaning validation activities for :
oParts washers
oFactory parts and components
oIsolator filling lines
Qualifications
Compensation
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Validation Engineer • Cary, NC, US
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