Process Validation Engineer
About the role
The Process Validation Engineer will execute process validation activities of oligonucleotide Active Pharmaceutical Ingredient (API) manufacturing within Agilent's Advanced Therapeutics Division.
Responsibilities
- Contribute to the development and refinement of manufacturing control strategies for oligonucleotide unit operations.
- Identify, assess, mitigate, and communicate process risks that may impact product quality, process performance, or regulatory compliance.
- Prepare and/or review process validation documentation including risk assessments, characterization plans/reports, technical assessments, control strategies, protocols, and summary reports.
- Perform or support process development studies, including planning, executing, and analyzing Design of Experiments (DOE) and Proven Acceptable Range (PAR) experiments.
- Support laboratory scale experiment execution to assess process risks and/or demonstrate robustness of process conditions.
- Lead and/or support execution of process validation studies in a CGMP manufacturing setting.
- Evaluate change controls associated with Process Performance Qualification (PPQ) or commercial processes.
- Evaluate process validation impact of nonconformances and review commercial batch records to ensure alignment with Process Control Strategies.
- Support continued process verification, including leading Continued Process Verification (CPV) plans, authoring CPV reports, and reviewing Product Quality Reports.
- Provide process validation-related updates to clients and project teams in the form of slides, memos, and reports.
Requirements
- Bachelor's degree (B. S.) or equivalent in chemistry, chemical engineering or related applied sciences field.
- 8+ 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.
- Knowledge and experience in process validation studies at the bench and in a plant setting.
- Knowledge and experience in designing, conducting, and statistical interpretation in Design of Experimentation (DOE), preferably using SAS JMP (or similar) software.
Qualifications
- Bachelor's degree (B. S.) or equivalent in chemistry, chemical engineering or related applied sciences field.
- 8+ 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.
- Knowledge and experience in process validation studies at the bench and in a plant setting.
- Knowledge and experience in designing, conducting, and statistical interpretation in Design of Experimentation (DOE), preferably using SAS JMP (or similar) software.
Benefits
This job offers a full-time weekly schedule. The full-time equivalent pay range for this position is $105,280.00 - $164,500.00/yr plus eligibility for bonus, stock and benefits. Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels.
Pay and Schedule
The full-time equivalent pay range for this position is $105,280.00 - $164,500.00/yr plus eligibility for bonus, stock and benefits. The job is full-time and requires occasional travel.
Schedule
The job is a day shift and does not have a fixed end date.
Job Function
The job function is Research & Development (R&D).