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US-CO-Boulder, United States of America
Onsite
Join Agilent’s mission to advance quality in life sciences and diagnostics. As a Product Quality Engineer, you will play a key role in ensuring compliance, reliability, and continuous improvement of our manufacturing and analytical processes. You’ll collaborate with cross-functional teams and customers to drive product quality and regulatory alignment throughout the development lifecycle—all while championing a culture of operational excellence and customer satisfaction.
Key Responsibilities
Serve as the Quality Assurance lead on product and analytical method development projects, ensuring alignment with internal QMS and external Quality Technical Agreements (QTAs).
Support compliance activities related to change control, risk management, validation, design control, and nonconformance handling.
Collaborate with clients and internal teams to define roles and responsibilities, and negotiate and implement QTAs.
Participate in audits and regulatory inspections, coordinating response efforts and supporting design assurance as needed.
Review and approve quality documentation, including change controls, SOPs, batch records, analytical reports, specifications, nonconformances, and CAPAs.
Provide training and consultative support on quality systems and processes to promote a strong quality culture.
Drive continuous improvement initiatives within the QMS and contribute to system and procedural enhancements.
Respond to customer inquiries and regulatory requests with clarity and professionalism.
Support Pre-Approval Inspection (PAI) readiness and related quality assurance activities.
Bachelor’s degree in Chemistry, Life Sciences, or a related field.
4+ years of experience in a GMP-regulated production or quality environment, or equivalent combination of education and experience.
In-depth knowledge of GMP guidelines, regulatory requirements, and API manufacturing/testing processes in a quality engineering capacity.
Experience with oligonucleotide or pharmaceutical manufacturing preferred.
Strong written and verbal communication skills, with a focus on technical writing and customer interaction.
Proficient in Microsoft Office and other relevant digital tools.
Strong organizational and time management skills, with the ability to set priorities and meet deadlines.
Ability to interpret technical documents and regulations, and respond effectively to internal and external stakeholders.
Additional Details
This job has a full time weekly schedule. Applications for this job will be accepted until at least July 6, 2026 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/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.