Process Validation Engineer at Agilent Technologies in Frederick, Colorado

Job Description:

Job Function
R&D

Travel Required
No

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 Process Validation Engineer designs Agilent products and specifies the components that make up the products. Designs and develops products, processes, systems, services or scientific applications using broad engineering concepts and research techniques. Documents research and design specifications. Facilitates transition of product design and enhancement to full production/delivery.

As a Process Validation Engineer in the Process Validation group, the candidate will execute 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.


• Provide 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 FDA's 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.


• Provide knowledge and ideas for process optimization, scale-up, and laboratory process transfer to mid and kilo-scale GMP manufacturing.

This position will report to the Frederick site. The option to work remotely is not available for this role.

Job Type
Experienced

Shift
Day Shift

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor's degree or equivalent in chemistry, chemical engineering or related applied sciences field


• 8+ years relevant experience and/or training; or equivalent combination of education and experience.


• 5+ years of experience in a GMP API setting.


• Knowledge and understanding of unit operations and associated control strategy of an oligonucleotide manufacturing process or like process.


• Experience in process validation studies at the bench and in a plant setting.


• Experience in the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities.


• Experience in designing, conducting, and statistical interpretation in Design of Experimentation (DOE), preferably using SAS JMP software is highly desirable.

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.

Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030.

For more information about equal employment opportunity protections, please see all of our notices for EEO below.

Option to Work Remote
Yes

Schedule
Full-time

Secondary Locations




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