POSITION OBJECTIVE: Oversees critical monitoring systems for multiple facilities. To review data from critical GMP operations: sterile and non-sterile manufacturing processes, warehouse and laboratory environmental controls. Able to support qualification and upkeep of manufacturing and laboratory equipment. 


Essential Job Functions/Responsibilities

  • Basic understanding of HVAC equipment, warehouse temperature controls, and environmental requirements for laboratory equipment (e.g., stability chambers).
  • Monitor facility systems for critical functions related to manufacturing processes, such as pressure differentials, temperature and humidity.
  • Risk assess environmental data and impact on product quality.
  • Support calibration and qualification of equipment used in manufacturing or laboratory operations.
  • Interface, collaborate, and communicate with internal customers and cross-functional teams on noticeable trends with critical facility functions.
  • Interface with external contractors and service providers.
  • Supports the continued maintenance and performance verification of facility, process, and laboratory equipment and instrumentation to ensure operation and accurate measurement data.
  • Supports documentation and reporting of facility performance metrics using Good Documentation Practices (GDP).
  • Supports maintenance and modification of plant utilities and infrastructure.
  • May perform other related duties as required and/or assigned.


Required Education & Qualifications

  • Bachelor’s degree in an engineering or scientific discipline (e.g., biochemistry).
  • Requires 2 or more years engineering or relevant experience. Thorough working knowledge of GMP requirements.
  • Working knowledge of HVAC systems
  • Must have a valid drivers license as this role supports multiple sites
  • Solid communication and problem solving skills required. Experience in participating in or leading root cause analysis and impact assessment.
  • Proficiency in the use of Excel, Word, PowerPoint, statistical software programs.
  • Proven ability to manage multiple tasks, prepare metrics, and meet deadlines.
  • Must be able to lift up to 25 pounds on a regular basis


Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. 


Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.


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