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Job Details


Amgen

Sr Associate Manufacturing (Business Systems)

Pharmaceuticals

All

Yearly

No

New Albany, Ohio, United States

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Does the idea of building an entirely new site from the ground up excite you? Do you love building and developing impactful teams? If you have a desire for talent development and want to be a part of Amgen’s mission to serve patients – every patient every time – then check out this new opportunity.

Be part of the Amgen Advanced Assembly and Final Product Operation, a new facility passionate about medical device assembly and packaging of injectable medicines. When completed, the Advanced Assembly and Final Product Operation facility will not only feature the best in-class assembly and packaging technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen’s plan to be a carbon-neutral company by 2027.

Sr. Associate Mfg. Execution Systems

Live

What you will do

Let’s do this. Let’s change the world. In this role you will support and provide technical leadership, lead all aspects of critical processes, and regularly draft and revise documents such as Electronic Batch Records (EBR), Standard Operating Procedures (SOP'S), and technical reports in a GMP regulated environment that supports the production process.

Responsibilities may include, but are not limited to:
  • Work in highly regulated GMP environment and adhere to compliance/regulatory standards and demonstrate a quality approach.
  • Design, revise, and maintain the Manufacturing Execution System (MES) e.g., Electronic Batch Records (EBRs), Master Data, Equipment Management (EQM), and Parameter Value Lists (PVLs).
  • Develop, revise, and maintain manufacturing related GMP documentation including but not limited to Standard Operating Procedures (SOPs), Work Instructions (WIs), technical protocols & reports.
  • Act as manufacturing business representative in multi-functional meetings and support all levels of the organization to drive projects.
  • Act as first line process Subject Matter Expert (SME) for manufacturing and MES.
  • Assist in the roll-out and implementation of new concepts and participate in continuous improvement initiatives for the Manufacturing area using MES.
  • Assist in Global Harmonization strategic activities including but not limited to design, improvements, system configuration, validation, and investigations.
  • Drive MES lifecycle management and represent the team during software upgrades.
  • Generate, own, and provide SME to Quality System records as minor deviations and CAPAs.
  • Conduct training to Manufacturing staff on new or revised processes and/or batch records.
  • Perform advance problem solving and assist during problem solving.
  • Support business system validation and process qualification.
  • Perform change assessments for the Manufacturing area.
  • Ensure all actions and responsibilities are completed on time and current schedule is maintained, accurate, and up to date, including proactive communication regarding scheduling errors or issues and provide possible solutions.
  • Track, analyze, and report scheduling metrics on schedule alignment, task alignment, and root cause analysis as required.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.

Basic Qualifications:

Master's Degree

Or

Bachelor's Degree and 2 years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Or

Associate’s degree and 5 years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Or

High school diploma / GED and 8 years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Preferred Qualifications:
  • Educational Background or experience in Science, Pharmaceuticals, Biotechnology and/or Engineering of medical devices.
  • Experience in a GMP environment and comprehensive understanding of the Manufacturing process with the ability to translate to an Electronic Batch Record.
  • Experience managing or supporting deviations, investigations, root cause analysis, CAPA’s and change controls.
  • Experience with Manufacturing execution systems, design, configuration, qualification/validation or interest in computerized systems and system integration supporting manufacturing and the end user e.g. MES, ERP, SCADA, Systech, Serialization.
  • Analytical fact-based problem solver and strong problem solving skills on process, equipment, and computerized systems.
  • Knowledgeable about process control methods and Lean principals (Kaizen process improvements).
  • Pro-active, result oriented, and ability to prioritize work to meet timelines.
  • Good documentation practices and skills including technical writing
  • Good communication to all levels of the organization.

Thrive

Some of the vast rewards of working here

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.

  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, 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.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.