Environmental Monitoring Specialist in Microbiology

2 weeks ago


Florham Park, New Jersey, United States Celularity Full time
Job Overview

Celularity Inc. is a pioneering biotechnology firm dedicated to advancing cellular medicine through innovative placental-derived allogeneic cell therapies aimed at treating cancer, immune disorders, and infectious diseases. Our commitment to harnessing the unique properties of the placenta allows us to create effective and accessible therapeutic solutions for significant global health challenges.

Position Summary

The Microbiology Specialist plays a crucial role in our Quality Control department, focusing on environmental monitoring, managing deviations, and ensuring laboratory readiness for microbiological testing. This position requires collaboration with various teams, independent task execution, result interpretation, and troubleshooting.

Key Responsibilities
  • Conduct routine laboratory tests, GTP, and GMP environmental monitoring, ensuring timely product release testing.
  • Perform final product assessments in controlled environments, ensuring accurate data review and timely release.
  • Adhere to aseptic gowning protocols, demonstrating proficiency in cleanroom practices and compliance with cGMP standards.
  • Maintain Good Documentation Practices by accurately completing environmental monitoring records and entering data into electronic systems.
  • Execute standard operating procedures (SOPs) to support Quality Control operations and provide technical updates to management as necessary.
  • Demonstrate meticulous attention to detail while performing repetitive technical tasks and adhering to cGMP requirements.
  • Utilize knowledge of microbiology and environmental monitoring techniques to assist in technical writing and data analysis.
  • Exhibit strong problem-solving skills and effective communication with peers and management to meet project timelines.
  • Contribute to investigations and corrective actions by writing deviations, out-of-specification (OOS) reports, and change controls.
  • Act as a key contributor to departmental projects and serve as a Subject Matter Expert (SME) in the absence of leadership.
Qualifications
  • Bachelor's degree in Biology or a related scientific field, with a preference for candidates with a microbiology background.
  • Minimum of 2 years of relevant experience in Environmental Monitoring within cGMP environments.
  • Strong organizational skills and the ability to work collaboratively in a team setting.
  • Excellent verbal and written communication skills, with a keen focus on detail.
  • Physical capability to perform tasks requiring mobility and strength, including routine gowning and lifting of materials.
  • Flexibility in scheduling, with the ability to work occasional weekends and off-hours as needed.
Preferred Skills
  • Familiarity with federal regulations governing Quality Systems and GMP manufacturing.
  • Demonstrated scientific creativity and technical proficiency in microbiological concepts.
  • Independent, self-motivated, and capable of initiating projects and improvements.
Working Environment

This position operates primarily in classified cleanroom environments, requiring adherence to strict gowning protocols and safety measures. The role demands a fast-paced approach and may require extended hours to support manufacturing activities.

Celularity is an Equal Opportunity Employer.



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