Description
**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:
1. 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.
2, 21 Code of Federal Regulations CFR Part 11, Good Manufacturing Practices, United States Pharmacopeia USP 697 and United States Pharmacopeia USP 1207.
3. 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.
4. Equipment validation including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
5. SolidWorks and MS Office Suite.
6. Domain knowledge for Strength of Materials, Material Selection and fluid mechanics.
**Contact:** Interested candidates please apply via https://careers.amgen.com/en/search-jobs and search for job # R-232599.
Job type: Full Time position. The annual salary range for this position in the U.S. is $120,354.84 – $149,145.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visit https://careers.amgen.com/life-at-amgen/benefits/
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
+ 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
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
