Manufacturing Process Technician Bulk Drug Substance Manufacturing Services Night Shift

Manufacturing Process Technician - Bulk Drug Substance Manufacturing Services - Night Shift

What you will do

Lets do this. Lets change the 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

• Associates 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 well 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.

Apply now and make a lasting impact with the Amgen team.

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 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.