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US-CO-Frederick, United States of America
Onsite
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. The responsibilities may include:
Control Strategies: 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).
Stage 1 Assessments/Evaluations: 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.
Stage 1 Characterization: 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.
Experiment Execution: 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.
Stage 2 CGMP Protocol Execution: Lead and/or support execution of process validation studies in a CGMP manufacturing setting.
PPQ and Commercial Support: 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.
Stage 3 CPV: 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.
Lifecycle: Supports all areas of process validation from FDAs Product Lifecycle’s Stages 1, 2, and 3.
Communication: Provide process validation-related updates to clients and project teams in the form of slides, memos, and reports.
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.
Additional Details
This job has a full time weekly schedule. Applications for this job will be accepted until at least July 1, 2026 or until the job is no longer posted.The full-time equivalent pay range for this position is $105,280.00 - $164,500.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locationsAgilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.