Product Quality Engineer

Job Description

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.

Qualifications

• 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.

Travel Required

• Occasional

Shift

• Day

Duration

• No End Date

Job Function

• Quality/Regulatory