Associate Director, MSAT - Cleaning Validation and Contamination Control Job at EPM Scientific, Rockville, MD

QjRpUm8yeE5CVE9LUXY4bUNCYlh5MC8rOWc9PQ==
  • EPM Scientific
  • Rockville, MD

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

Insight Global

Materials Coordinator Job at Insight Global

Title: Materials Coordinator 12 month contract to hire Location: Groton, CT 5x a week onsite Must-haves Experience doing Administrative support Experience planning and scheduling experience Strong experience with MS Office, specifically Excel Experience...

Insight Global

Physical Security Manager Job at Insight Global

 ...Job Description: The Physical Security Manager, Americas, will oversee and manage security operations across the Americas region. This role involves developing and implementing security protocols, conducting risk assessments, managing security teams, and ensuring... 

Leeds Professional Resources

Senior Financial Analyst Job at Leeds Professional Resources

 ...We are seeking a Senior Financial Analyst to join our client's team! The ideal candidate will be responsible for managing multiple financial...  ...landscape to provide recommendations for strategic financial planning. Evaluate potential investment opportunities, including... 

LHH

Buyer Job at LHH

 ...Job Title: Buyer Location: Mt. Vernon, Ohio Salary: $65,000 - $80,000 per year Employment Type: Direct Hire Shift: First Shift Travel: Some travel required Company: LHH Recruitment Solutions on behalf of our client Job Description: LHH Recruitment... 

Smart House Mate LLC

House Cleaning Professionals Job at Smart House Mate LLC

 ...Cleaners to join our team.Applicants should be equipped with their cleaning supplies, have reliable transportation, and be tech-savvy (or...  ...for somewhere you cangrow, and have aknack for customer service, we'd love to speak with you. Responsibilities Clean all...