Cleaning Validation Engineer - Program Development

New Yesterday

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:
o Parts washers
o Factory parts and components
o Isolator filling lines • Author 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.
Qualifications • 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.
Compensation • $75 - $85/hour • Company-Subsidized Benefits: Medical, Dental, Vision, 401K-with match, PTO, Sick Leave as required by law, and Holidays
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Location:
Cary

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