Sr Associate, Manufacturing (Technical Authoring)

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. 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 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.

Job Posting Title

Sr Associate, Manufacturing (Technical Authoring)

Live

What you will do

Lets do this. Lets change the world. In this role you will support the manufacturing team and provide technical expertise to regularly draft and revise documents such as Standard Operating Procedures (SOP'S), protocols, technical reports, and training material in a GMP regulated environment that supports the manufacturing process.

• Develop, review, and update technical content including but not limited to standard operating procedures, work instructions, risk assessments, protocols & reports for manufacturing team.
• Provide technical and clerical support to the manufacturing team in the preparation of documentation, collation of data and tracking of technical documents.
• Liaise with manufacturing team and other cross functional departments regarding documentation changes in an effective and timely manner.
• Collaborate with multiple departments to support new/revise training documentation for manufacturing staff.
• Support process owners and participate in continuous process improvement and / or troubleshooting projects.
• Support manufacturing team in reducing document turnaround times.
• Ensure documentation related actions are completed on time and current schedule is maintained, accurate, and up to date.
• Develop protocols for Manufacturing to support change controls, deviations & troubleshooting investigations with provision from relevant SMEs.
• Generate, own, and provide subject matter expertise to Quality System records as minor deviations, CAPA and change control records.
• Track pending activities required to support change control implementations.
• Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current operating systems.
• Share knowledge with members of the manufacturing team.

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 in Science and/or Engineering.

Or

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

Or

Associates Degree in Science and/or Engineering 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 and/or biotechnology industry.
• Experience in a Good Manufacturing Practices (GMP) environment and demonstrated background in technical writing.
• Experience with device assembly and packaging of final product.
• Ability to translate highly technical information into easily understandable information for manufacturing operators.
• Dynamic skills and usage of photographs, drawings, diagrams, animation, and charts that increase users understanding.
• Experience supporting deviations, investigations, CAPAs and change controls.
• A fact-based problem solver with strong troubleshooting and problem-solving skills.
• Pro-active with the ability to prioritize work to meet benchmarks
• Good documentation and communication

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 increase your potential along your career path
• A diverse and inclusive community of belonging, where teammates are encouraged 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

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.