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

dTV4dmZ3YmpPbEczTXB0UkQvNE9lNTFiUWc9PQ==
  • 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

Town House Restaurant & Jack’s Steak House

Jacks Barman Job at Town House Restaurant & Jack’s Steak House

 ...Jack's Steak House - Contratacin inmediata de camarero Te apasiona crear deliciosos ccteles y brindar un servicio excepcional a los huspedes? nase a nuestra familia de trabajo en Jack's Steak House, donde hemos estado sirviendo a la comunidad de Uvalde durante... 

Chrysler Museum Of Art

Environmental Technician Job at Chrysler Museum Of Art

 ...Job Description Job Description Job Title: Environmental Technician Division: Facilities FLSA Classification: Non-Exempt...  ...and according to established organizational and departmental policies and procedures, responsible for the cleaning activities that... 

New Freedom Corporation

Accounting Bookkeeper QuickBooks In Office Job at New Freedom Corporation

 ...Job Description We are looking for a part time Accounting Bookkeeper to join our team! You will be responsible for preparing and analyzing...  ...in accounting or other related fields Working knowledge of QuickBooks Fundamental knowledge of GAAP Experience with current... 

ProDrivers

Experienced CDL Driver for Flatbed and Heavy Haul Job at ProDrivers

 ...team as an experienced CDL Driver specializing in Flatbed and Heavy Haul transportation! We are looking for reliable drivers who are...  ...process. Responsibilities: Operate flatbed or heavy haul trucks on both local and regional routes. Secure loads safely and... 

Cherokee Temps, Inc.

Skilled Construction Laborer Job at Cherokee Temps, Inc.

 ...Local construction company looking for long term contract construction laborer. Potential temp-to-perm placement based on performance. Required skills include: - 1-2 years experience - knowledge of various power/hand tools - must be proficient w/ a tape measure...