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 knowledge and technical expertise 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.
• Evaluate change controls associated with Process Performance Qualification (PPQ) or commercial processes.
• 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

Full-time equivalent pay range: $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.

Travel Required: No

Shift: Day

Duration: No

End Date: Not Specified

Job Function: R&D