Process Validation Engineer

Job Description

As a Process Validation Engineer in the Process Validation group, the candidate will be responsible for developing, optimizing and validating oligonucleotide processes for the pharmaceutical industry supporting Active Pharmaceutical Ingredient (API) manufacturing.

Responsibilities:

• Responsible to facilitate multiple aspects of an API process qualification strategy through designing/ authoring/executing/reporting/ investigating of process qualification studies.
• Responsible for leading all aspects of process validation through characterization and process performance qualification.
• Conducts process validation by leading and executing validation studies at the bench and protocol driven studies at scale in a GMP environment.
• Provide work product updates to clients and project teams in the form of presentations, slides, memos and reports.
• Contribute knowledge and ideas to the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities.
• Design, executing and reporting of Design of Experiments (DOE) and associated statistical software calculations to support design space understanding, process validation and process consistency as it relates to oligonucleotide process control and operations.
• Contribute to preparing chemical process descriptions and writing technical reports to support internal technology transfer into manufacturing and support in preparation of client Chemistry, Manufacturing and Controls (CMC) submissions.
• Understands and complies with process validation requirements under current FDA, EMA and ICH guidance's.
• Maintain process compliance integrity by adhering to standard operating procedures (SOP's) and current good manufacturing practices (cGMP) as appropriate.

Qualifications

• Bachelor's degree (B. S.) or equivalent in chemistry, chemical engineering or related applied sciences field
• 8+ years relevant experience and/or training; or equivalent combination of education and experience
• Demonstrated experience in leading process qualification studies at the bench and in a plant setting
• Demonstrated experience in the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities
• Demonstrated experience with process design, transfer and validation for API manufacturing
• Demonstrated experience with adhering to current ICH, USP, FDA, EMA guidance's and standards for process validation pertaining to the manufacture of API's
• Knowledge of and skill in using computer software and hardware applications
• DOE software is helpful

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Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least April 1, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $103,200.00 - $161,250.00/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/locations

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity 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 diversity in the workplace 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.

Travel Required:
No

Shift:
Day

Duration:
No End Date

Job Function:
R&D