Performs routine manufacturing operations for the production of clinical and commercial products. Performs manufacturing activities of full scope, including but not limited to, protein purification manufacturing, clean-in-place procedures, ultrafiltration/diafiltration operations, filtration and aseptic processing.
Operates production equipment according to SOPs. May be required to assist with writing and editing SOPs, and maintenance of production equipment. Maintains records and clean room environment to comply with regulatory requirements, GMPs, and SOPs.
A clear understanding of manufacturing processes and the ability to readily identify deviations in processes, controls, and guidelines is required. Receives assignments in the form of objectives with goals and process to meet goals outlined. Work is reviewed by supervisor to measure meeting of objectives.
Accomplishes tasks mainly through direct operation of cGMP activities.
Performs daily operations of the work unit and actively assists coworkers in fulfilling department goals. Operates computers for process control and data entry; follows standard operating procedures; manufacturing tickets, forms good manufacturing practices, and safety guidelines; and recognizes and reports any abnormal events or circumstances
Education and Experience Requirements
Prefer 1-3 years of experience in Manufacturing operations or related GMP field, or graduate of industry certificate program. Experience in Purification processes and/or other industry groups a plus.
AA 1-3; HS 2-4
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives
Shire is an Equal Opportunity and Affirmative Action Employer
Shire - 18 months ago
Shire plc (Shire) is a specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its...