Job Description: The Principal Quality Engineer – Commercial Quality is accountable for providing quality oversight of final product activities, ensuring that Quality Systems identified for commercial sustainment and life cycle management of commercially available final product, including devices and combination products, are appropriate and compliant. Manages high complexity programs with greater risk to the business including those which are novel or new to Amgen, electromechanical, and/or internally developed. Responsible to represent FPTQ Commercial in external engagements. Provides oversight of proper quality resource balancing on project(s) as required, ensuring FPTQ resources are proactively managed. Reviews and approves Design History File (DHF) content and technical documentation and assessments throughout the commercial lifecycle, including content from suppliers and partners. Participates in ongoing evaluation of commercial final product requirements, in particular for specialized products. Approve device components and final product or the device constituent of a combination product specification as part of commercial program. Establishes and maintains the quality requirements for commercial process transfer. Participate in technical aspects of problem-solving, complaints, and other investigations for commercial products. Maintenance of Traceability Matrix and final product quality play. Key participant at design reviews. Quality approver of Design History File. Ensures that all Quality Requirements have been met and DHF is ready for GMP inspections, Inspection Readiness Activities, and Partner Audits. Obtains, reviews, and confirms readiness of documentation for inspections. Ensures control strategies have been established, implemented, and maintained throughout the commercial lifecycle. Represents FPTQ at TCP or External Engagement initiatives as necessary. Acts as delegate for head of FPTQ Commercial Quality as needed. Job Responsibilities: Attend commercial program meetings as required as part of program working teams. Contribute to content and review of regulatory submissions and RTQs, and support audits and inspections for associated projects related to life cycle management of commercial programs. Provide Quality technical expertise, Quality oversight, and a single point of Quality contact for Final Product Technologies activities. Maintain Traceability Matrix and provide review and approval for subordinate project plans and associated projects and contribute to applicable Design Control Phase Design Reviews. Participate in audits and inspections, well-prepared including all relevant details supported by evidence. Projects may include secondary packaging, primary container, mechanical, electrical, and/or software as part of the system(s). Represent and participate in onsite supplier due diligence visits, as needed, in support of supplier investigations and qualification activities. Ensure program alignment and proper linkages within the Design and Development Plans, Risk Management Documentation, and Control Plans. Provide oversight and review of Human Factors Engineering (HFE) Protocols and Reports, as well as onboarding and auditing HFE suppliers related to life cycle management of commercial programs. Scope may include a wide range of products, including but not limited to vial, prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and on-body injector systems. Participate in deviation, CAPA, and Complaint investigations for commercial programs. Provide input to change controls for projects, and review and approve relevant Design Control documentation. Provide guidance on documentation structures created during lifecycle management activities. Collaborate to develop complete formal written responses. Responsible for identifying proper GMP documentation strategies and repositories required to ensure compliance with applicable regulations and Amgen Procedures. Ensure adherence to all relevant commercial final product regulations and standards. Work cross-functionally with individuals and project teams to ensure success of commercial project efforts. Provide Quality oversight of Design Characterization, Verification and Validation activities as required through change control and/or CAPA for life cycle management of commercial programs. Qualification & Experience: Doctorate degree and 2 years of Quality experience Master’s degree and 6 years of Quality experience Bachelor’s degree and 8 years of Quality experience Associate’s degree and 10 years of Quality experience High school diploma / GED and 12 years of Quality] experience 7+ years of quality and manufacturing experience in biotech or pharmaceutical industry Bachelor's degree in a Science field Experienced in NPI/NPD Ability to convey and defend quality perspective to various levels of stakeholders Participate in full audit cycle Ability to interface with Regulators, and articulate knowledge of their process Ability to respond to RTQs both verbally and in writing Ability to interpret technical standards, internal requirements, and regulations Leadership skills and the ability to oversee multiple complex projects simultaneously Working knowledge of quality engineering and/or mechanical engineering Job Details: Company: Amgen Vacancy Type: Full Time Job Location: Tampa, FL, US Application Deadline: N/A Apply Here vacancyoptions.com
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