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

MFVPSWVHSlJnQ3dFZjlpdG0zSVpQR082Q2c9PQ==
  • 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

STAUD

Assistant Allocator Job at STAUD

 ...happens after youve found it. STAUD has an opening for an Assistant Allocator, working a hybrid schedule out of their Los Angeles...  ...-to-consumer retail network of 10+ store locations. This entry-level role focuses on data management, reporting, and operational support... 

Aequor

Operational Specialist Job at Aequor

 ...Job Title: Operations Specialist, Scheduling and Cell Logistics Duration: 12 Months Location...  ...a minimum of 50% of the time. Remote work must be performed at home with consistent...  ...external stakeholders over the phone and email Ensure a positive end-to-end customer... 

LAW OFFICE OF NEDA AGUIRRE, APC

Associate Attorney - Family Law Job at LAW OFFICE OF NEDA AGUIRRE, APC

 ...Ready to ditch the long commute without sacrificing your income or career growth? If you're a motivated and experienced Family Law attorney, this could be the perfect opportunity for you. At our growing Temecula-based law firm, we offer more than just a job we... 

Senior Suites Of Urbandale

Housekeeper/Maid Job at Senior Suites Of Urbandale

Senior Suites of Urbandale is a Family oriented Assisted Living /Residential Care Community. Our seniors and staff take pride in the cleanliness of our community and individual living areas. We are currently in need of a part time Housekeeper to be a part of our family...

Manpower

HVAC Instructor - Part Time Job at Manpower

 ...We are seeking an HVAC Instructor on a Part Time basis who will be responsible for sessions lasting 6-week periods. Please review the details below! The position does not require teaching experience but will require HVAC knowledge as guidance and materials will be provided...