Sr. Associate Mfg Execution Systems
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.
Sr. Associate Mfg. Execution SystemsLive
What you will do
Lets do this. Lets change the world. In this vital role you will support Drug Product Inspection and Packaging and Solid Dosage AML1 and AML 23 organizations. Will provide technical leadership, supervise critical processes, implement routine validation protocols, 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 a Non-Standard Shift operation.The specific responsibilities include, but are not limited to:
- Perform advance troubleshooting and assist in the review of documentation for assigned functions.
- Participate on cross-functional teams and represent the MES team.
- Generate, own and provide subject matter expertise to Quality System records as minor deviations, CAPA and Change Control Records.
- Identify, recommend, and implement improvements and/or changes in MES (EBR, Equipment Management) including routine or other functions as requested.
- 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.
- Facilitate meetings and track the pending activities required to support change control implementations.
- Represent MES team in cross-functional meetings and projects.
- Track, analyze and report scheduling metrics on schedule adherence, task adherence, and root cause analysis as required.
- Conduct training to staff and share knowledge with other members of the MES team.
- 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.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Sr. Associate Mfg. Execution Systems professional we seek is an individual contributor with these qualifications.
The Basic Qualifications are:Master's Degree
Bachelor's Degree & 2 years of manufacturing experienceBeyond that, the additional preferred qualifications are:
- Educational Background in Business Administration, Science and/or Engineering
- Experience working in GMP pharma, medical devices and/or biotechnology industry
- Experience managing or supporting deviations, investigations, CAPAs and change controls
- Strong troubleshooting skills on process equipment
- Hands on experience with Werum PAS|X configuration, testing and validation environments and ERP experience (e.g. SAP)
- Good documentation skills including technical writing
- Good Communications in both Spanish and English
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 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.
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.Amgen requires all staff in the United States and Puerto Rico 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.