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For your reference, we have included the original job posting below.
Associate Manufacturing - Clinical Fill
Job Number:
41379424
Company Name:
Amgen
Job Location:
Thousand Oaks, CA US
Job Categories:
Engineering & Architecture Science & Biotech
Associate Manufacturing - Clinical Fill
Will routinely assist in performing complex to critical processes according to Standard Operating Procedures in the Manufacturing area. Individual will be responsible for the manufacturing of sterile products. Individual will perform a variety of operations involving the support of aseptic filling, primarily operation of automated fill equipment inside the aseptic environment.
Major duties will include: • Operation of the fill/stoppering equipment to dispense sterile product into glass containers • Environmental monitoring of the aseptic environment during each fill and after each fill • Loading and unloading of sterile products from freeze dryers • Operation of the continuous particulate monitoring system during each fill • Assembling and disassembling of equipment before and after use • Performing operations during fills by following proper procedures • Trouble-shooting may include mechanical adjustments to the fill line. • High levels of housekeeping to conform to cGMP standards • Cleaning and sanitizing aseptic filling areas to maintain the quality of the product • Detailed and accurate documentation in batch production records.
Basic Qualifications • Bachelor's degree OR • Associate's degree & 4 years of directly related experience OR • High school diploma / GED & 6 years of directly related experience
Preferred Qualifications Candidates must be available for non standard shift including weekends. Bachelor's Degree in Life Sciences or Engineering and experience working in a manufacturing & production area •Ability to assemble, disassembles, operate and understand complex equipment per procedures •Experience with lab equipment and computers •Automation experience is highly desirable •Experience in parenteral manufacturing (filling and formulation area) •Intermediate mathematical skills •Clear, concise writing skills •Organizational skills •Basic problem solving skills •Ability to interact constructively with peers •Ability to understand, applies, and evaluates basic chemistry, biology, and physical principles •Candidates should understand basic computer skills, have GMP knowledge, good cGMP Documentation skills, and be able to assemble, disassemble, operate and understand equipment per procedures. •Must be able to determine availability of components and assign accordingly. •Must be able to perform in the aseptic filling areas while maintaining the integrity and cleanliness of these areas by utilizing aseptic gowning requirements and techniques.
