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

S29Gd29DS1hvOFE1SHF1UnZsek0zSDA4VUE9PQ==
  • 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

Department of Political and Peacebuilding Affairs

Political Affairs Officer (IFI Partnership), New York City Job at Department of Political and Peacebuilding Affairs

 ...the Peacebuilding Support Office (PBSO) in the Department of Political and Peacebuilding Affairs (DPPA). The Political Affairs Officer...  ...support of peacebuilding efforts of the United Nations, in consultation with all relevant stakeholders; Reviews and monitors peacebuilding... 

DIRECTV

Warehouse Assistant (IBEW-FLD) Job at DIRECTV

When you join DIRECTV, you'll be a part of a team that's supporting our customers from the front lines. Whether it's connecting them to the latest technology or getting them plugged into our world-class services, your work will create connections and support our mission... 

Bloom Health Centers

Psychiatric Physician Assistant Job at Bloom Health Centers

 ...Evaluation Medication Management rTMS (optional) The Physician Assistant position at Bloom Health Centers is a full-time position that operates through a hybrid of in-person and telehealth psychiatric outpatient care. Starting salary is dependent upon... 

Rheem Manufacturing

NDN-Shipper/Receiver I Job at Rheem Manufacturing

 ...Days, 4PM-12:30AM) The Shipper/Receiver I is responsible for assembling prepack materials, picking orders, putting away product to assigned locations, packing orders, packaging bulk product into individuals to make available for sale, and inspecting product for damage.

Minnesota Department of Transportation

Heavy Equipment Mechanic Job at Minnesota Department of Transportation

 ...trucks which includes, but not limited to performing skilled diagnostics via advanced technology computer software to troubleshoot mechanical and electrical/electronic problems for the repair and maintenance work on engines and drive drain, hydraulic and emission systems...