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.
What you will do
Lets do this. Lets change the world. In this dynamic role you will join the Manufacturing Systems team which is responsible for supporting manufacturing activities through new product introduction, improvement project implementation, supporting the multiproduct facility operation program, CAPA ownership, deviation trending, and optimization/ implementation of single use technologies.Responsibilities include:
- Leading a team of manufacturing specialists.
- Supporting and leading single use systems within manufacturing including issue resolution and design changes
- Writing validation protocols and reports in support of cleaning validation, equipment commissioning, qualification, and change management.
- Demonstrating strategic problem solving skills and champion continual improvement.
- Managing sophisticated projects using project management skills.
- Applying sophisticated process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the detailed delivery of new technologies into the plant.
- Handling Quality Records, such as CCMS, CAPA, and deviations.
- Drafting and revising GMP manufacturing documents (SOPs, Forms)
What we expect of you
We are all different, yet we all use our distinctive contributions to serve patients. The manufacturing professional we seek is diligent with these qualifications.Basic Qualifications:
- Doctorate degree OR Masters degree and 3 years of manufacturing and operations experience OR Bachelors degree and 5 years of manufacturing and operations experience OR Associates degree and 10 years of manufacturing and operations experience OR High school diploma / GED and 12 years of manufacturing and operations experience
- Degree in Engineering or Life Sciences
- Experience in GMP Technical Support roles, GMP operations, Engineering, or Process Development
- Technical knowledge of drug substance processing and broad understanding of related disciplinary areas
- Ability to successfully communicate sophisticated technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
- Ability to coach, mentor and/or cross train colleagues within core technical area
- Ability to drive results through leadership of cross-functional teams
- Experience leading and managing projects and people
- Equipment and Cleaning Validation experience
- Understanding of single-use technologies
- Data analysis and/or data visualization skills
- Availabliltiy to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute validation and project tasks with minimal disruption to operations.
- Ability to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance.
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.
#Operations21Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your 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 a 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 an accommodation.
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.