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

ZGJScTlQaW0xZk4vbTBCdE45R1d3Z0JCU2c9PQ==
  • 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

LHH

Production Artist Job at LHH

Production Artist LHH Recruitment Solutions is currently seeking a production artist with 2 or more years of experience for a contract opportunity for a well-established food and beverage company. This position is fully onsite in Austin, TX. This is a great role that...

Wyndham Destinations

Brand Ambassador (Face-to-Face) Job at Wyndham Destinations

 ...growing portfolio of resort, travel club, and lifestyle travel brands. Our dedicated associates help the company achieve its mission...  ...festivals, and conferences to connect with the public as a brand ambassador for Wyndham Destinations. In this sales-based role, engages in... 

Provado Health

Driver / Medical Transportation Provider Job at Provado Health

 ...~ Must live in Miami Dade County ~ We need drivers to transport people to and from their medical appointments. ~ Desired Shift: Drivers get to create their own schedules, business hours, Monday through Friday. ~ We have prescheduled, standing order member... 

Pryor Associates Executive Search

Spanish-speaking Actuarial Trainee - PR12945 Job at Pryor Associates Executive Search

Spanish-speaking Actuarial Trainee opening in Miami. Learn how to price reinsurance for Latin American Property & Casualty business. Ideal candidate has 2+ actuarial exams and proficiency in Spanish. No experience required. (PR12945)

FACCES Careers

Chef/Cook Job at FACCES Careers

 ...Chef/Cook Schedule will be anywhere from 25-35 hours a week, and must be ok working with children We are a premier school located in Columbus, Ohio, with a nationally accredited program for children. FACCES at Starting Point has a state-of-the-art kitchen, and...