Under general supervision, the Manufacturing Process Technician will routinely perform simple to moderately-complex processes according to Standard Operating Procedure and Batch Records. Generally, this will include all aspects associated with bulk manufacturing in aseptic and non-aseptic environments.
There are multiple openings for this position.
Equipment and parts cleaning using manual and automated methods and equipment
Assembly, disassembly, cleaning, and steaming of portable and stationary tanks and associated equipment
Operation and process monitoring of clean systems, autoclaves, and processing equipment
Sample collection, processing, storage and delivery
Product and component reconciliation
Solution preparation and transfer
Materials handling, weighing and dispensing, power industrial vehicle operation
Strict adherence to current Good Manufacturing Practices (cGMP's), responsible to accurately complete process-associated documentation, make calculations and perform the physical tasks associated with bulk manufacturing and other duties as assigned.
Associate's degree and 2 years of Manufacturing or Operations experience
2 years in a technical school setting with hands-on experience
High school diploma / GED and 4 years of Manufacturing or Operations experience
1+ plus years of experience in a GMP/ other regulated environment.
Demonstrated knowledge of GMP principles.
Drug substance manufacturing experience.
Ability to stand or sit for extended periods of time.
Ability to maintain focus during repetitious tasks over the course of a shift.
Ability to assemble, disassemble, operate and understand simple to moderately complex equipment per procedures.
Basic understanding of measurements, calculations and the metric system
Ability to work effectively in an individual and team setting.
Ability to document process tasks in electronic batch records.
Coachable, ability to take coaching/critique and show learned/measurable improvement.
Capacity to follow written procedures, recognize and report malfunctions.
Strong communication skills.
Ability to perform assignments with a high degree of focus/attention to detail.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Associated topics: biomedical, biomedical engineer, bioprocess, biosynthetic, enzyme, fermentation, metabolic, molecular, nutrition, pain