Manufacturing Specialist – Single Use Systems (SUS)

Career Category

Manufacturing

Job Description

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.

Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities but it will also integrate sustainability innovations to reduce carbon and waste as part of Amgens plan to be a carbon-neutral company by 2027.

Manufacturing Specialist Single Use Systems (SUS)

What you will do

Lets do this. Lets change the this vital role you will be part of the Manufacturing Support team which is responsible for manufacturing activities such as new product introduction new technology and equipment introduction continuous improvement projects supporting CAPA ownership deviation trending and optimization / implementation of single use technologies. The position is within the drug substance organization in Amgen North Carolina at Holly Springs. This role is critical for Amgen North Carolinas success and key in supporting single-use (SUS) operations.

• Support New Product introduction and projects through SUS mapping / drawing.
• Maintain and edit SUS Standard Operating Procedures (SOP).
• Support manufacturing and quality through the SUS defect / leak triage process perform troubleshooting on the floor initiate investigations and bring leaks and defects to triage meetings.
• Initiate Event Notification (EN) / Supplier Investigation / Corrective Action (SICAR) records and follow process to conclusion including collaborating with vendors on investigation.
• Maintain up-to-date EN / SICAR / Early Engagement (EEnew item) trackers and manage or lead small to medium projects.
• Provide input for ANC representative to SUS network for improvements and troubleshooting.
• Support Vendor Change Notification assessments.
• Understand single-use material capabilities and user requirements for new technologies through interaction with end users.
• Collaborate with Continuous Improvement (CI) leads to help SUS improvement projects and provide / lead use cases for continuous improvement projects. For example improvements around tubing management material kitting and flow.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. We are looking for a detail-oriented partner with an understanding of manufacturing operations and a passion for single-use systems with the following qualifications.

Basic Qualifications :

Preferred Qualifications :

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 well support your journey every step of the way.

In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

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.

Salary Range

88378.00 USD - 106188.00 USD

Required Experience :

IC

Key Skills

Lean Manufacturing,Six Sigma,Continuous Improvement,ISO 9001,Lean Six Sigma,Management Experience,Manufacturing & Controls,5S,Manufacturing Management,Kaizen,Chemistry,Manufacturing

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 106188 - 106188