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

QjQrUXJHaE5CaitDUnY0bkR4UFJ5azcvK1E9PQ==
  • 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

Christus Health

Armed Security Officer - Alamogordo Job at Christus Health

DescriptionSummary:Uniformed position at all times. Armed Security Officer's duties include being a visible deterrent to criminal activity, providing security for patients, Associates, and visitors, protecting and patrolling hospital buildings, assets and premises as... 

ERM

Environmental Technician Job at ERM

 ...ERM is hiring an experienced Leak Detection and Repair ( LDAR) Technician (Full-time ) for full-time project-based assignments at a client campus in Indianapolis, Indiana . In this critical role, you will be responsible for assisting with routine LDAR monitoring... 

ADNM and ABC 123 Dental Group

Dentist Cleburne - ADNM and ABC 123 Dental Group - Cleburne, Texas, United States Job at ADNM and ABC 123 Dental Group

General Dentist $250,000+ Guaranteed Compensation with a Clear Path to $400,000+ Location: [City, State] Are you ready for a dental career that offers unmatched growth, guaranteed financial stability, and a team that's invested in your success? Imagine a future where...

Cymbiotika

Warehouse Associate Job at Cymbiotika

 ...Qualifications High School Diploma or equivalent preferred. Ability to work in a team environment. Ability to work in a fast-paced, time-sensitive environment. Ability to work well under stress and minimal supervision. Previous working experience as a Warehouse... 

bet365

Senior UI-UX Designer Job at bet365

 ...You will work within the Product Design team in the Design and UX department, who are responsible for the strategic design, visual direction and development of our product. With a new focus on the US market, we are looking to craft innovative mobile app experiences that...