Amgen Specialist Manufacturing, MES (Master Batch Record) 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.
Specialist Manufacturing, MES
What you will do
Let’s do this. Let’s change the world. In this role, the candidate will have experience in a pharmaceutical or biotech industry and demonstrate competency in leading projects and teams to deliver Manufacturing Execution Systems (MES) designs within project timelines. Responsible for the design, authoring, implementation, and validation of the Electronic Batch Records. Responsible for the development, configuration and testing of Master Batch Records (MBRs) from initial to final design and provide business oversight of the MES system across the site. This role is a key communication and technical interface for Amgen Advanced Assembly and Final Product Operation.
Responsibilities may include, but are not limited to:
Represents the plant on global MES network and initiatives
Liaison with Amgen MES core-team to troubleshoot and develop new ways of working.
Responsible for the support and ongoing development of the Amgen MES system in development of MBRs and continuously improving the MES business process.
Responsible for drafting, carrying out, and reviewing Application Lifecycle Management test scripts and test sets for testing MBR design.
Responsible for training of Electronic Batch Record (EBR) end-users (Supervisors, Operators, Technical/QA/Support staff).
Uses a variety of data analysis tools and methodologies; applies knowledge and experience to solve systematic problems and improve process efficiencies.
Responsible for any applicable equipment integration design, configuration and testing to allow MBR interaction with shop floor equipment - OSI PI, Recipe Managers – DeltaV.
Responsible for resolving interface errors and stock discrepancies between ERP/MES as required.
Responsible for leading MBR development design reviews including collaborating with Operations, Process Development and Quality functions.
Responsible for providing technical support where required by Operations leadership.
Project Management and Team Building
Experience in cross functional Project Management.
Lead multiple assignments and processes.
Independently resolve approach to projects.
Independently develop solutions that are detailed, practical, and consistent with functional objectives.
Partners and communicates optimally with other departments and support functions to ensure positive working relationships.
Extends capabilities by working closely with senior staff / experts within and outside organization.
Ability to coach, mentor and/or cross train colleagues within core technical areas.
Compliance and Quality
Own and manage deviations, corrective actions and change controls related to MES and related areas.
Assist with Corporate, FDA, and other regulatory bodies during company audits.
Collaborate with Regulatory and Quality partners to manage change control records and respond to regulatory questions and/or audit findings associated with MES in the plant.
Accountable for the safe operation of the area ensuring all safety policies are adhered to and that any incidents are reported in a timely manner. Promotes a positive safety culture.
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.
Master’s degree and 3 years of Manufacturing, Engineering or Science experience.
Bachelor’s degree and 5 years of Manufacturing, Engineering or Science experience.
Associate’s degree and 10 years of Manufacturing, Engineering or Science experience.
High School Diploma/GED and 12 years of Manufacturing, Engineering or Science experience.
Working knowledge of manufacturing in pharmaceutical/biotech industries
Broad technical experience in manufacturing batch records, process design and MES systems
Experience with PAS X, Werum software
Experience of working in bulk manufacturing operations or have a demonstrated capacity to learn quickly and adapt to new technology
The ability to adapt quickly to the demands of commercial manufacturing operations
Extensive experience with electronic documentation systems in a regulated environment
Innovative & analytical with strong process improvement mentality
Knowledge of regulation requirements (GMP & GAMP)
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.
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.