Job Description

The Cleaning Validation and Contamination Control Lead is responsible for defining and implementing robust, agile strategies for cleaning validation and contamination control across the site. This role will lead the continuous improvement initiatives of the cleaning validation and contamination control strategy and provide support during investigations for any issues related to microbial contamination.

Key Responsibilities:

• Develop and maintain site-wide cleaning validation and contamination control strategies aligned with regulatory expectations and industry best practices.
• Provide deep technical expertise to resolve complex cleaning validation challenges.
• Lead or participate in risk assessments and investigations related to contamination and cleaning validation. Ensure high-quality, well-documented investigation reports.
• Drive the advancement of contamination control and cleaning validation programs, including governance and continuous improvement initiatives.
• Act as the primary point of contact for inspection readiness activities related to contamination control and cleaning validation.
• Support new product introductions by providing contamination control expertise, including microbial risk assessments and input into equipment and process design.
• Contribute to cross-contamination prevention initiatives across the Global Supply Chain (GSC), including the development of standards within the Quality Management System (QMS).

Qualifications:

• Bachelor's degree in a relevant scientific discipline required.
• Strong knowledge in bioprocess engineering, cleaning validation for commercial processes, and contamination control strategies.
• 15+ years of experience in biopharmaceutical process development, MSAT, or CMC roles.
• Extensive experience with commercial-scale cleaning validation and contamination control.
  • Including ability to lead contamination control and cleaning validation programs.
• Proven expertise in large-scale stainless steel bioprocesses.
• Experience supporting DS manufacturing and cross-functional technical problem-solving.
• Must have biologics experience.

Job Tags

Similar Jobs