Career Category
OperationsJob Description
Amgen Rhode Island is one of the premier biologics drug substance manufacturing sites in the world with a long history of operational excellence and highly successful commercial and clinical operations.
Solutions Prep is looking for a talented Manufacturing Associate. The successful incumbent will join a night shift team working a 12-hour shift. The shift pattern will be 7PM-7AM with a two-week rotation covering 7 days per week. The rotating shift offers several benefits, with an average of 14 days on shift per month with every other weekend off. In addition, any Sundays worked receive Premium pay.
Under general supervision the Manufacturing Associate will perform batching and transfer of Buffers and Medias in appropriate areas according to Standard Operating Procedures (SOPs). Associate will be required to know, comprehend, and apply good GMP practices, as well as understand, follow and document in batch records. Associate will perform and monitor critical processes, execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports. Associate must work well in teams and adhere to the floor operating principles. Associate will also perform basic troubleshooting and assist in the review of documentation for assigned functions. In addition, Associate may identify, recommend, and implement improvements related to routine functions.
Basic Qualifications:
- Bachelor's degree
- OR
- Associate's degree and 4 years of Manufacturing or Operations experience
- OR
- High School diploma/GED and 6 years of Manufacturing or Operations experience.
Preferred Qualifications:
- Bachelor’s degree in Science or Engineering
- Knowledge of large-scale biotechnology operations such as purification, cell culture, aseptic processing, etc
- Knowledge of Single-use-Systems
- CFR and Regulatory knowledge
- Mechanical ability/expertise
- Basic statistical mathematical skills
- Ability to interpret and apply GMP knowledge
- Understanding of analytical methods for manufacturing area
- Demonstrated technical writing capability
- Able to demonstrate project management skills and presentation skills
- Ability to understand, apply and evaluate basic chemistry, biology and physical principles
- Basic troubleshooting skills on production equipment
- Experience with Delta V
- Experience with lab equipment/testing
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