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.
Does the thought of building an entirely new site from the ground up excite you? Do you love building and developing impactful teams? If you have a passion for talent development and want to be a part of Amgens 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 focused on 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 Amgens plan to be a carbon-neutral company by 2027.
Sr. Associate Digital ManufacturingLive
What you will do
Lets do this. Lets change the world. In this role you will lead various smart manufacturing technology and computerized systems initiatives within manufacturing to support the end user on the shop floor (e.g. AR/VR Technology, MES, ERP, SCADA, Systech, Serialization). Will manage critical processes, provide technical leadership, and be accountable for designing, implementation, and validation of these systems and digital technologies. Responsible for regularly drafting and revision of master batch records, technical reports, and other Good Manufacturing Practices (GMP) documents that supports smart manufacturing technology and the production process. This role is essential for Amgen Ohios success and key in supporting operations towards the digital future of tomorrow.
Responsibilities may include, but are not limited to:
- Provides technical support, project management, and problem solving assistance of various smart manufacturing technology and computerized systems within the manufacturing area.
- Department lead of smart manufacturing technology, computerized systems, and Manufacturing Execution System (MES) and represent site on global networks and initiatives.
- Support the site in the project approvals, prioritization, and manage the roll-out and implementation of smart manufacturing technology concept initiatives for the manufacturing area.
- Support Amgen Ohio digital manufacturing team to trouble shoot and develop new ways of working.
- Act as manufacturing business representative in multi-functional meetings and support all levels of the organization to drive digital manufacturing projects.
- First line Subject Matter Expert (SME) for smart manufacturing technology, computerized systems, and MES.
- Assist in global harmonization strategic activities for digital manufacturing which include but not limited to design, improvements, system configuration, validation, and investigations.
- Support digital manufacturing lifecycle management and represent team during software or system upgrades.
- Generate, and review documents (SOPs, FORMs, Deviations, CAPA, CC, etc.) associated and owned by digital manufacturing team.
- Work with team to ensure training on new or revised digital manufacturing processes is effective and completed for end-users (Operators/Supervisors/Technical/QA/Support Staff).
- Trouble shoot and assist during problem solving.
- Uses the latest data analysis tools and methodologies to solve systematic problems and improve process efficiencies to maintain production schedule alignment.
- 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.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek is a collaborative partner with these qualifications.Basic Qualifications:
Masters Degree within Manufacturing, Engineering, or Computer Science experience.Or
Bachelors Degree and 6 months of Manufacturing, Engineering or Computer Science experience.Or
Associates Degree and 2 years of Manufacturing, Engineering or Computer Science experience.Or
High School/GED and 4 years of Manufacturing, Engineering or Computer Science experience.Preferred Qualifications:
- Educational Background or experience in Science, Pharmaceuticals, Biotechnology, Digital Technology, and/or Engineering.
- Experience with design, configuration, qualification/validation in smart manufacturing and computerized systems and system integration supporting manufacturing and the end user on the shop floor (e.g. MES, ERP, SCADA, Systech, Serialization).
- Experience in a GMP environment and background in smart manufacturing technologies and computerized systems and comprehensive understanding of the Manufacturing process with the ability to translate to an Electronic Batch Record. (PAS X, Werum Software)
- Experience in deviations, investigations, root cause analysis, CAPAs and change controls.
- Analytical fact-based problem solver and strong trouble shooting skills on process, equipment, smart technology, and computerized systems.
- Ability to maintain an environment of operation excellence, continuous improvement, and lean manufacturing (Kaizen process improvements).
- The ability/experience working in fast paced manufacturing environment where issues must be assessed, understood, and resolved immediately to be able adapt quickly to the demands of commercial manufacturing operations.
- 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.
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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
Join UsIf 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.