Mfg Assoc III

Amgen is the leading human therapeutics company in the biotechnology industry. Our mission is to serve patients. We foster a culture of innovation, using our expertise in advanced science and technology to find new and better medicines to fight serious illness. For more information about Amgen, our visionary science, and our powerful medicines, visit www.amgen.com.Amgen is committed to promoting and maintaining an inclusive, high-performing culture where all team members embrace and leverage each others' talents and backgrounds, nourish innovative thinking, achieve their full potential, and contribute to Amgen's success. Our commitment to diversity is articulated in our core values and reflected in every part of our organization. As an EEO/AA M/F/V/D employer, Amgen values and encourages diversity in the workplace.As a member of our world class manufacturing team you will be involved in a fast paced dynamic environment dedicated to producing high quality products for use in clinical trials.With minimal supervision, employees will perform manufacturing processes according to Standard Operating Procedures in a clean room environment.
Specific responsibilities include:
'Hands-on operation, set-up, cleaning, and sanitization of production equipment'Prepare buffers, perform and monitor critical processes'Draft and revise standard operating procedures'Review and execute validation protocols
'Perform preventive maintenance on equipment
'Initiate quality incident reports
'Identify, recommend, and implement improvements related to routine functions
'Direct operators on critical processes'Perform complex troubleshooting
'Assist in the review of documentation for assigned functions (equipment logs, batch records)'On a rotational basis will be responsible for team leadership activities during new product introductions. This includes scheduling floor activities, and logistical coordination with regard to raw materials, equipment, and resources required for successful campaign completion.'Position may require occasional weekend or holiday work, and overtime as dictated by the production schedule
REQUIREMENTS
Bachelor's Degree in Biology/Life Sciences required. 5 to 7 years of related experience also required. Additional requirements include mechanical ability/expertise, basic understanding of equipment and processes, and basic statistical mathematical skills. Candidates should be able to interpret and apply GMP knowledge, understand analytical methods for manufacturing area, and demonstrate technical writing capability. Successful candidates will also demonstrate project management skills, presentation skills, and be able to independently collaborate with outside resources. CFR and Regulatory knowledge also required.