Process Validation Engineer
Agilent boulderUpdate time: May 27,2020
Job Description

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.

The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines.

Agilent Technologies Nucleic Acids Solutions Division is looking to add a Process Validation Engineer to their Process Validation team working at their state-of-the-art, contract Active Pharmaceutical Ingredient manufacturing facilities located in Boulder and Frederick, Colorado.

Job Description

As a Process Validation Engineer in the Process Validation group, the candidate will contribute to multiples aspects of process validation in support of Active Pharmaceutical Ingredient (API) manufacturing.

 

 

  • Assist in the development of manufacturing control strategies of an API process qualification strategy through authoring/executing/reporting/ investigation of process qualification studies.
  • Perform process characterization / validation studies at the bench and in a plant setting, including contributing to the design and writing of the study and associated study documents.
  • Contribute knowledge and ideas for the development of manufacturing control strategies.
  • Support Continued Process Verification by monitoring attribute and parameter controls with statistical interpretation.
  • Supports various aspects of process validation in the Product Lifecycle Stage 1 and Stage 2.
  • Provide work product updates to clients and project teams in the form of slides, memos and reports.
  • Maintains process compliance integrity by adhering to standard operating procedures and current good manufacturing practices.
  • Contribute knowledge and ideas for process optimization, scale-up and laboratory process transfer to mid and kilo scale GMP manufacturing.

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