Senior Engineer

Amgen • Thousand Oaks, CA

5d • Remote

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Engineer What you will do and what we expect of you Let’s do this. Let’s change the world. In this vital role you will: Duties: Work with team of engineers in the development, validation, qualification and transfer of Title 21 of the Code of Federal Regulations (CFR) Part 11 compliant physical test methods for Container Closure Integrity (CCI) of combination products and primary containers; Ensure that primary containers carrying oncology and cardiovascular drug products maintain sterility throughout the container lifecycle, including product filling, transportation, storage, to reach the patients safely; Act as a subject matter expert (SME) regarding Container Closure Integrity Testing to support product filings, qualification of manufacturing processes, and maintenance of routine stability studies; Design, develop, and calibrate fixtures for American Society for Testing and Materials ASTM F2338 compliant vacuum decay testing of vials on Packaging Technologies and Inspection PTI-325 and PTI-440 leak detectors using SolidWorks; Develop, validate and transfer physical test methods for deliverable volume testing of primary containers carrying drug products per United States Pharmacopeia USP 697 and Good Manufacturing Practices (GMP); Work with industry experts to advance innovative system integrity methods such as Helium Leak Detector, Wilcomat Leak Detector, high voltage leak detection, and other new emerging technologies; Serve as a domain expert for Strength of Materials, Material Selection, fluid mechanics/mass spectrometry, and transport phenomena; Principal author for test method documentation including technical method instructions, operational protocols, equipment qualification, standard operating procedures (SOPs), and technical drawings related to equipment function. May Telecommute.

Requirements

• Master’s degree or foreign equivalent in Mechanical Engineering, Biomedical Engineering or related field & completion of a university-level course, research project, internship, thesis, or one year of experience in the following:
• Maintain processes for the development, qualification validation and transfer of container closure integrity test methods for product verification, of new products and transfer of knowledge and techniques to partners.
• 21 Code of Federal Regulations CFR Part 11, Good Manufacturing Practices, United States Pharmacopeia USP 697 and United States Pharmacopeia USP 1207.
• Develop operational procedures and maintenance protocols for various Container Closure Integrity test equipment including vacuum decay, helium leak detection, tracer liquid and high voltage leak detection technologies.
• Equipment validation including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• SolidWorks and MS Office Suite.
• Domain knowledge for Strength of Materials, Material Selection and fluid mechanics.

Responsibilities

• Work with team of engineers in the development, validation, qualification and transfer of Title 21 of the Code of Federal Regulations (CFR) Part 11 compliant physical test methods for Container Closure Integrity (CCI) of combination products and primary containers
• Ensure that primary containers carrying oncology and cardiovascular drug products maintain sterility throughout the container lifecycle, including product filling, transportation, storage, to reach the patients safely
• Act as a subject matter expert (SME) regarding Container Closure Integrity Testing to support product filings, qualification of manufacturing processes, and maintenance of routine stability studies
• Design, develop, and calibrate fixtures for American Society for Testing and Materials ASTM F2338 compliant vacuum decay testing of vials on Packaging Technologies and Inspection PTI-325 and PTI-440 leak detectors using SolidWorks
• Develop, validate and transfer physical test methods for deliverable volume testing of primary containers carrying drug products per United States Pharmacopeia USP 697 and Good Manufacturing Practices (GMP)
• Work with industry experts to advance innovative system integrity methods such as Helium Leak Detector, Wilcomat Leak Detector, high voltage leak detection, and other new emerging technologies
• Serve as a domain expert for Strength of Materials, Material Selection, fluid mechanics/mass spectrometry, and transport phenomena
• Principal author for test method documentation including technical method instructions, operational protocols, equipment qualification, standard operating procedures (SOPs), and technical drawings related to equipment function

Benefits

• stock
• retirement
• medical
• life and disability insurance
• eligibility for an annual bonus or for sales roles, other incentive compensation
• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Senior