About this role
Manufacturing Process Technician - Bulk Drug Substance Manufacturing Services - Night Shift
What you will do
Let’s do this. Let’s change the world. In this vital role you will be a Mfg. Process Technician in the manufacturing organization at Amgen North Carolina (ANC). The essential position, which supports our critical 24/7 manufacturing operations, works a 12-hour 2-2-3 schedule from 5:45pm to 6:15am. Mfg. Process Technician will complete operations on the floor in the Services area and are responsible for the manufacturing of cGMP (current Good Manufacturing Practices) drug substances.
With general direction for routine work and detailed instructions for new assignments, the Mfg. Process Technician will support all floor operations in accordance with cGMP practices. As Amgen relies upon the regular attendance of staff members to meet legitimate business needs, staff must be able to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime in support of our 24/7 operations.
Responsibilities will include…
Compliance:
- Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance.
- Ensure proper gowning and aseptic techniques are always followed
Process/Equipment/ Facilities:
- Perform hands-on operation including set-up, cleaning, sanitization, monitoring of equipment in assigned area
- Buffer and Media preparation and transfer
- Weigh and dispense of materials to be used in the preparation of Buffers and Medias
- Complete washroom activities: cleaning equipment, small to large scale, use in production activities
- Run and monitor critical process per assigned procedures
- Perform documentation for assigned function (i.e., equipment logs, EBRs)
- Maintain an organized, clean, and workable space
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The hard-working professionals we seek are team players with these qualifications.
Basic Qualifications:
- High school diploma / GED + 1 year of manufacturing and/or other regulated experience Or
- Associate’s degree
Preferred Qualifications:
- Completion of NC BioWorks Certificate Program
- Experience in a regulated industry such as biotechnology or pharmaceutical
- Basic understanding of GMP principles
- Strong verbal and written communication skills
- Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
- Ability to perform assignments with a high degree of focus/attention to detail.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Amgen is committed to fostering an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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, disability status, or any other basis protected by applicable law.
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.