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

MGZWQUVjeGxLeStrQmY0Zys0SjlXNEJ0aUE9PQ==
  • 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

Yexgo

Data Entry Operator Needed - Work From Home Job at Yexgo

 ...Excellent typing skills and proficiency in data entry software and tools. Strong attention to detail and accuracy. Ability to work independently and meet deadlines. Good communication skills, both written and verbal. High school diploma or equivalent;... 

Russell Tobin

Pharmacy Technician Job at Russell Tobin

We're looking for a Pharmacy Technician for our client in Elmhurst, NY 11370. Please find below details of the position. Title : Pharmacy Technician (Sterile experience preferred) Location : Elmhurst, NY 11373 Duration : 13-Weeks Contract Shift: 1:00 PM...

Carpet City Flooring Center - Eagle River, WI

Warehouse Associate Job at Carpet City Flooring Center - Eagle River, WI

 ...family-owned flooring store. We all work better when we're having fun on the job. Perfect job for a high school student! The warehouse associate is responsible for accurately processing orders for pickup and delivering in a timely manner while maintaining a neat... 

Crown Chrysler Dodge Jeep Ram- OH

Car Washer Job at Crown Chrysler Dodge Jeep Ram- OH

Crown Chrysler Dodge Jeep Ram needs Car Washers / Valets due to our continued business growth! Duties Include:* Keeping service drive clear by moving / parking cars * Washing customers cars and vacuuming Crown Automotive Group is GROWING and there is... 

Insight Global

Production Supervisor Job at Insight Global

 ...Semiconductor manufacturing preferred Job Description A partner of Insight Global is looking to add a Production Unit Supervisor to their team. The Production Unit Supervisor is responsible for the safe, consistent daily operation of the production of Photovoltaic...