Senior Engineer- Process Development/NPI
Description:
Job Details
Join Amgens Mission of Serving Patients
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Senior Packaging Equipment Engineer- Process Development/NPI
What you will do
Lets do this. Lets change the world. In this role you as a member of the Amgen Ohio, Process Development organization, this role serves as project manager and technical expert for Final Drug Product New Process Introductions (NPI) into Amgen Ohio. NPI scope may include the implementation of various drug product formats (e.g. vial, syringe, auto injectors, etc.), introduction of new processes and equipment (including medical device final assembly and testing), and implementation of new packaging configurations.
The Senior Engineer engages Drug Product development teams throughout the commercialization process, leading multi-functional NPI teams with support from Manufacturing, Supply Chain, Quality, Engineering, Capital Projects, Process Development and other business groups. Primary responsibilities include leading the NPIs for necessary process, facility, equipment, materials, and training modifications; development of project execution plans; ensuring process requirements are effectively transferred into manufacturing; and coordination/execution of NPI activities, which may include document preparation or revision, change control management, manufacturing process modifications, equipment and technology implementation (design through qualification), and supporting manufacturing readiness activities. Work with various NPI support groups to develop, maintain, and implement the NPI project plan. Senior Engineer will function as the NPI project manager and is accountable for NPI scope, schedule, resources, and risk management. Responsibilities include issue resolution in a timely manner and partner concern to different levels of management as appropriate.
Engage with network partners to develop process and technology strategies that achieves clinical/commercial development schedules while minimizing transfer risks.
Collaborate with Combination Product Operations, Quality, and Regulatory partners to manage change control processes and respond to regulatory questions and/or audit findings within the scope of the NPI.
Support generation, revision, review, execution, and approval of relevant technical documents (e.g., manufacturing procedures, protocols, training materials, design control deliverables, and specifications).
Ensure design/process transfer requirements are appropriately implemented and aligned with current manufacturing strategies.
Support a safe working environment by staying in sync with all pertinent environmental health/safety practice, rules and regulations.
Lead and manage change control processes for New Product Introductions (NPI), ensuring timely approvals, regulatory compliance, and seamless implementation across cross-functional teams.
Monitor and track NPI-related changes to ensure proper risk assessment, mitigation strategies, and alignment with project timelines.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek will possess these qualifications.
Basic Qualifications:
Doctorate degree
Or
Masters degree and 2 years of Process Development, Engineering, or NPI experience
Or
Bachelors degree and 4 years of Process Development, Engineering, or NPI experience
Or
Associates degree and 8 years of Process Development, Engineering, or NPI experience
Or
High school diploma / GED and 10 years of Process Development, Engineering, or NPI experience
What you can expect from 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, well 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
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.
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.
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world's leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together-to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we're transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
Company info
Website Phone Location Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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