Process Validation Engineer, Expert

Agilent Technologies•Frederick, MD

11d•Remote

About The Position

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 for a Process Validation Engineer to join their Process Validation team working at their state-of-the-art, contract Active Pharmaceutical Ingredient manufacturing facility that specializes in oligonucleotide chemistries located in Boulder and Frederick, Colorado. Job Description As a Process Validation Engineer within the Process Validation team of Agilent Technologies Nucleic Acid Solution Division, the candidate will be responsible for executing process validation activities of oligonucleotide Active Pharmaceutical Ingredient (API) manufacturing. The responsibilities may include: Compile, generate and review process inputs and outputs using statistical process control measures for product quality and process consistency reports. 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. Facilitate multiple aspects of an API process qualification strategy through designing/ authoring/executing/reporting/ investigating of process qualification studies. Contribute knowledge and ideas for the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities. Support the design and execution of Design of Experiments (DOE) and Proven Acceptable Range (PAR) experiments for design space understanding and process validation as they relate to oligonucleotide upstream and downstream operations. Supports all areas of process validation from FDAs Product Lifecycle Stages 1, 2 and 3. 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.

Requirements

Bachelor's degree (B. S.) or equivalent in chemistry, chemical engineering or related applied sciences field
Knowledge and 8+ experience in a GMP API setting.
Knowledge and understanding unit operations and associated control strategy of an oligonucleotide manufacturing process or like process.
Knowledge and experience in process validation studies at the bench and in a plant setting.
Knowledge and experience in the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities.
Knowledge and experience in designing, conducting, and statistical interpretation in Design of Experimentation (DOE), preferably using SAS JMP software is highly desirable

Responsibilities

Compile, generate and review process inputs and outputs using statistical process control measures for product quality and process consistency reports.
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.
Facilitate multiple aspects of an API process qualification strategy through designing/ authoring/executing/reporting/ investigating of process qualification studies.
Contribute knowledge and ideas for the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities.
Support the design and execution of Design of Experiments (DOE) and Proven Acceptable Range (PAR) experiments for design space understanding and process validation as they relate to oligonucleotide upstream and downstream operations.
Supports all areas of process validation from FDAs Product Lifecycle Stages 1, 2 and 3.
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.