Agilent Technologies · 2 months ago
Process Validation Engineer, Expert
US-CO-Boulder
Full-time
Hybrid
Senior Level, Lead/Staff
$105K/yr - $164K/yr
8+ years expAgilent Technologies is a company that inspires and supports discoveries that advance the quality of life. They are seeking a Process Validation Engineer to execute process validation activities for oligonucleotide Active Pharmaceutical Ingredient (API) manufacturing, contributing to the design and execution of various studies and ensuring compliance with manufacturing standards.
BiotechnologyHealth CareHealth DiagnosticsLife SciencePharmaceutical
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
Qualification
Required
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
Benefits
Bonus
Stock
Benefits
Company
Agilent Technologies
Agilent Technologies addresses the scientific and laboratory management needs of analytical scientists and clinical researchers.
10001+ employees
H1B Sponsorship
Agilent Technologies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (51)
2024 (56)
2023 (58)
2022 (70)
2021 (64)
2020 (53)
Funding
Current Stage
Public CompanyTotal Funding
$500M2019-09-05Post Ipo Debt· $500M
1999-11-26IPO
Leadership Team
Mike McMullen
CEO and President
Padraig McDonnell
President and CEO
Recent News
Research & Development World
2026-01-09
News-Medical.Net
2025-12-24
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