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 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