Process Validation Engineer

Agilent Technologies•Frederick, MD

14d

About The Position

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 Validated 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.
4+ years relevant experience and/or training; or equivalent combination of education and experience.
3+ 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 Validated 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.