Senior Associate Manufacturing - Electronic Batch Record Support

Amgen

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Senior Associate Manufacturing - Electronic Batch Record Support What you will do Let’s do this. Let’s change the world. In this vital role, you will have the outstanding opportunity to support the start-up of the Amgen North Carolina (ANC) manufacturing facility. This is a manufacturing support role responsible for the generation of electronic documentation, for tracking of EBR metrics and for communication between the operations teams and the various functional groups working through start-up activities. During start up, Manufacturing Senior Associates will have oversight of electronic batch records operational readiness activities in multiple manufacturing areas such as: Dispensing, Buffer/Media Preparation, Upstream Cell Culture, Harvest, Downstream Purification, Analytical Testing, and Column Packing. Manufacturing Senior Associates can also support Standard Operating Procedure (SOP) creation, review, and approval; design of job aids and work instructions, advancement of digital tools to support manufacturing operations, and training of staff. Manufacturing support focused on Electronic Batch Record (EBR) generation using PAS-X (Korber), editing, real-time troubleshooting and managing the EBR validation for new or modified processes. Assist in the implementation of new MES integrations and functionalities. Support manufacturing in the troubleshooting and execution of EBRs Create and maintain Electronic Batch Records Generation of paper process documents when required. Contribute to Lean Transformation through recording EBR metrics and application of continuous improvement tools. Participate and contribute to projects to introduce new products and/or advancement of new manufacturing technologies into the plant. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative team player with these qualifications.

Requirements

High School/GED and 4 years of manufacturing or operations work experience OR Associate’s Degree and 2 years of manufacturing or operations work experience OR Bachelor’s Degree and 6 months of manufacturing or operations work experience OR Master’s Degree

Nice To Haves

Completion of NC BioWorks Certification Program.
Experience in biotechnology or pharmaceutical plant start up.
Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment.
Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation.
Excellent verbal and written communication (technical) skills.
Proficient Microsoft Office skills, and knowledge of other electronic systems such as SAP, EBR/MES, Delta V, and Electronic Quality Systems.
Experience with PAS X (Korber) or comparable software for electronic batch records with some understanding of editing and validation.

Responsibilities

Manufacturing support focused on Electronic Batch Record (EBR) generation using PAS-X (Korber), editing, real-time troubleshooting and managing the EBR validation for new or modified processes.
Assist in the implementation of new MES integrations and functionalities.
Support manufacturing in the troubleshooting and execution of EBRs
Create and maintain Electronic Batch Records
Generation of paper process documents when required.
Contribute to Lean Transformation through recording EBR metrics and application of continuous improvement tools.
Participate and contribute to projects to introduce new products and/or advancement of new manufacturing technologies into the plant.

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