Process Validation Engineer

Agilent Technologies•Boulder, CO

6d•$105,280 - $164,500•Onsite

About The Position

Agilent Technologies Advanced Therapeutics Division (previously Nucleic Acids Solutions Division) is looking for a Process Validation Engineer to join their Process Validation team working at their state-of-the-art, contract Active Pharmaceutical Ingredient manufacturing facility that specializes in oligonucleotide chemistries located in Boulder and Frederick, Colorado. As a Process Validation Engineer within the Process Validation team of Agilent's Advanced Therapeutics Division (ATD), the candidate will be responsible for executing process validation activities of oligonucleotide Active Pharmaceutical Ingredient (API) manufacturing.

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 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 is highly desirable.

Responsibilities

Contribute knowledge and technical expertise to the development and refinement of manufacturing control strategies for oligonucleotide unit operations (examples: synthesis, deprotection, ultrafiltration, purification, annealing, concentration, lyophilization).
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. May include planning, executing, and analyzing Design of Experiments (DOE) and Proven Acceptable Range (PAR) experiments to support design space understanding and process validation as they relate to oligonucleotide upstream and downstream process operations.
Support laboratory scale experiment execution (occasional) to assess process risks and/or demonstrate robustness of process conditions. This may include set-up and operation of laboratory equipment. Document bench experiments in accordance with good documentation practices (GDP), analyze results, summarize findings, and provide recommendations based on outcomes.
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.
Review commercial batch records to ensure alignment with Process Control Strategies.
Support continued process verification, which may include but is not limited to leading Continued Process Verification (CPV) plans, authoring CPV reports, and reviewing Product Quality Reports.
Supports all areas of process validation from FDAs Product Lifecycle’s Stages 1, 2, and 3.
Provide process validation-related updates to clients and project teams in the form of slides, memos, and reports.