Manufacturing Services Process Technician (Night Shift) Multiple Positions

About the position

At Amgen, we are committed to serving patients and driving innovation in biotechnology. As a Manufacturing Services Process Technician, you will play a crucial role in our new FleX Batch facility, which combines cutting-edge disposable technologies with traditional stainless-steel equipment. This facility is designed to maximize operational flexibility and features best-in-class drug substance manufacturing technologies, integrated with industry 4.0 capabilities. Additionally, we are dedicated to sustainability, aiming to reduce carbon emissions and waste as part of our goal to become a carbon-neutral company by 2027. In this vital role, you will be responsible for supporting all floor operations in accordance with current Good Manufacturing Practices (cGMP). Your work will involve hands-on operations, including the setup, cleaning, and monitoring of equipment, as well as the preparation and transfer of buffers and media. You will ensure compliance with established procedures and policies, maintain a clean and organized workspace, and document your activities accurately. The position requires a commitment to safety and adherence to strict compliance standards, making it essential for you to follow proper gowning and aseptic techniques at all times. The initial schedule for this position will be Monday to Friday, with 8-hour days, transitioning to a 12-hour night shift that includes every other weekend as business needs dictate. This role offers the opportunity to work from home initially, but you will be expected to perform your duties on-site as the schedule changes. Join us in this meaningful role and contribute to our mission of improving patient lives through innovative biotechnology solutions.

Responsibilities
?? Complete work in accordance with established cGMP procedures and policies.
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?? Perform hands-on operation including set-up, cleaning, sanitization, and monitoring of equipment and assigned area.
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?? Prepare and transfer buffers and media.
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?? Weigh and dispense materials for buffer and media preparation.
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?? Complete washroom activities, including cleaning equipment used in production activities.
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?? Run and monitor critical processes per assigned procedures.
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?? Document assigned functions, including equipment logs and EBRs.
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?? Maintain an organized, clean, and workable space.

Requirements
?? High school diploma / GED + 1 year of manufacturing and/or other regulated experience OR Associate's degree.
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?? Completion of NC BioWork Certificate Program.
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?? Experience in a regulated industry such as biotechnology or pharmaceutical.
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?? Basic understanding of GMP principles.
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?? Strong verbal and written communication skills.
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?? Proficient Microsoft Office skills and knowledge of electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems.
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?? Ability to perform assignments with a high degree of focus and attention to detail.

Nice-to-haves
?? Completion of NC BioWork Certificate Program.
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?? Experience in a regulated industry such as biotechnology or pharmaceutical.

Benefits
?? Comprehensive employee benefits package including health, dental, and vision coverage.
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?? Retirement and Savings Plan with generous company contributions.
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?? Life and disability insurance.
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?? Flexible spending accounts.
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?? Discretionary annual bonus program.
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?? Stock-based long-term incentives.
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?? Award-winning time-off plans and bi-annual company-wide shutdowns.
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?? Flexible work models, including remote work arrangements.

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