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Amgen Sr. Associate (MES) Manufacturing Execution Systems in New Albany, Ohio

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.

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, supervise 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:

  • Design, identify, and implement improvements and/or changes in MES (EBR, Equipment Management) including routine or other functions as requested.

  • Drive lifecycle management for MES and represent team in cross-functional meetings and projects.

  • Provide first line MES support to production process and train staff on new/revised processes.

  • Perform advance troubleshooting and assist in the review of documentation for assigned functions.

  • Ensure all actions are completed on time and current schedule is maintained, accurate, and up to date, including proactive communication regarding scheduling errors and issues and provide possible solutions.

  • Generate, own, and provide subject matter expertise to Quality System records as minor deviations, CAPA and Change Control Records.

  • Conduct training to production staff and share knowledge with other members of the MES team.

  • Facilitate meetings and track the pending activities required to support change control implementations.

  • Course, analyze, and report scheduling metrics on schedule adherence, task adherence, and root cause analysis as required.

  • Assist in Global Harmonization strategic activities including but not limited to validations.

  • Assess system configuration to ensure the designs are aligned with cGMP requirements.

  • Generate, review pre and post approve test script.

Win

What we expect of you

We are all different, yet we all use our outstanding 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 in Science and/or Engineering.

  • Experience working in GMP pharma, medical devices and/or biotechnology industry

  • Experience in a Good Manufacturing Practices (GMP) environment and comprehensive understanding of translating Manufacturing process execution in electronic Batch Record design.

  • Experience managing or supporting deviations, investigations, CAPA’s and change controls

  • Hands on experience with Werum PAS|X configuration, testing and validation environments and ERP experience (e.g. SAP)

  • Analytical fact-based problem solver and strong troubleshooting skills on process equipment

  • Pro-active, result oriented, and ability to prioritize work to meet timelines

  • Strong problem-solving skills and knowledge in Lean principals (Kaizen process improvements)

  • Good documentation skills including technical writing

  • Good Communications in both Spanish and English

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we 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.

Apply now for a career that defies imagination

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

careers.amgen.com

#AMGENOHIO

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.

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