Process Validation Engineer
Agilent Technologies
full-time
Posted on:
Location Type: Office
Location: Frederick • Colorado • 🇺🇸 United States
Visit company websiteSalary
💰 $87,600 - $136,875 per year
Job Level
Mid-LevelSenior
About the role
- 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.
Benefits
- health insurance
- retirement plans
- paid time off
- flexible work arrangements
- professional development
- bonuses
- stock options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
statistical process controlprocess characterizationprocess validationDesign of ExperimentsValidated Acceptable Rangeprocess optimizationscale-uplaboratory process transfersynthesizingpurifying
Soft skills
communicationcollaborationproblem-solvinganalytical thinkingattention to detail