Cleaning Validation Engineer - Program Development

ZP Group • Cary, NC

113d • $75 - $85

About The Position

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.

Requirements

• 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.

Responsibilities

• Develop and implement a robust cleaning validation program aligned with cGMP, FDA, EMA, and other global regulatory requirements.
• Lead cleaning validation activities for parts washers, factory parts and components, and 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.

Benefits

• Medical
• Dental
• Vision
• 401K-with match
• PTO
• Sick Leave as required by law
• Holidays

What This Job Offers

• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 251-500 employees