HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Sr. Engineer - Primary Container EngineeringLive
What you will do
Lets do this. Lets change the world. In this role you will report into the Primary Container Engineering (PCE) department under the Manufacturing Science and Technology (MSAT) Group within the Combination Product Operations (CPO) in Thousand Oaks, CA. This position will lead the initiation, design, and delivery of projects, particularly in primary container design, characterization, and qualification. Position requires the application of engineering principles to successfully perform the job functions. This role will bring to bear technical skills and the ability to coordinate and communicate across different functions to successfully complete projects. The Sr. Engineer shall have the ability to work on multiple projects at one time that may involve changes or new product, processes, tooling, or equipment introduction to improve quality and reliability and reduce cost.
This role will be required to:
- Employ basic engineering skills and practices to capture user requirements and translate them into technical documentation for execution.
- Assist with project definition by performing engineering studies/assessments for drug delivery systems for characterization/qualification in a GMP environment.
- Perform field evaluations of existing systems and provide engineering design recommendations.
- Design, development, and qualification of primary container systems.
- Design and development of physical test methods with respect to container and combination product integration of drug delivery systems.
- Provide detailed data analysis and recommendations to enable senior staff to make informed decisions.
- Lead primary component technical activities within Process Development and external partners.
- Capable of machine design from initial conception through fabrication and into implementation.
- Investigate and develop new processes required to improve manufacturing operations. Improvements may be required for a variety of reasons (i.e. quality, reliability, new product introduction, cost saving).
- Implement projects per MSAT/CPO and company procedures to ensure projects are completed on schedule and within established budget.
- Provides authorship and expert technical leadership for regulatory filings
- Lead/support creation and management of design inputs and outputs including design input requirements, specifications, user needs.
- Ensure quality through integration of requirements, risks, and implemented mitigations through downstream design outputs
- Provide hands-on technical support for primary component issues related to customer complaints, aseptic filling, lyophilization and inspection operations for the manufacture of commercial biopharmaceuticals.
- This position will operate in a highly matrixed environment and collaborate with multi-functional teams, communicate and elevate technical or strategic issues to team members and management and make recommendations and/or decisions to guide successful execution of various processes.
- Own and support quality records (i.e., Change Control, Deviation, )
- Support and/or lead technical workstreams/projects
What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients. The engineering professional we seek is a [type of person] with these qualifications.Basic Qualifications:
Masters degree and 3 years of Engineering or related experience
Bachelors degree and 5 years of Engineering or related experience
Associates degree and 10 years of Engineering or related experience
High school diploma / GED and 12 years of Engineering or related experiencePreferred Qualifications:
ThriveWhat you can expect of us
- 3 years of experience in the biotechnology/pharmaceutical industry
- 3 years of experience in primary container, medical devices, etc.
- 3 years of experience in testing, equipment, method, and mechanical design
- Experience including statistical analysis, design of experiments, ANOVA analysis, Gage R&R, Tolerance stack-up analysis
- Project management experience/ Multi-tasker to enable managing multiple priorities
- Proficiency in SolidWorks/CAD/Drawings/Assemblies
- Design for Manufacturing (DFX)/Design for Assembly (DFA)
- Knowledgeable about Design Controls / Combination Products
- Knowledgeable about Regulatory Standards and Compendial Requirements Problem solving / Root Cause Analysis
- Flexible/Highly adaptive to continuous changing priorities/environment
- Strong oral and written communication skills, including the ability to coordinate and communicate across different functions and sites in order to successfully complete projects
- Strong technical writing skills
- Strong mechanical engineering and material science knowledge
- Experience with the manufacturing process of primary container systems (glass/elastomers/polymers) for medical (aseptic) applications
- Work history with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing
- Aseptic fill/finish experience
- Fast and continuous learner
- Ability to travel to international locations assisting our development partners during implementation of specific container requirements into their processes
As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising 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 including:
- 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 and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
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.
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.