Product Quality Engineer

Agilent Technologies•Boulder, CO

18h•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

Experience with oligonucleotide or pharmaceutical manufacturing preferred.

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.