Cleaning Validation Engineer - Program Development

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 aCleaning Validation Engineerto lead the development and implementation of a world-class cleaning validation program.

Assignment Profile

As aCleaning 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

· 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