Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics. Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.Operate Clean-in-Place (CIP) and Steam-in-Place systems.Assemble valve assemblies and filter cartsOperate general production equipment (such as autoclave, COP washer, etc.)Execute Electronic Batch Management (EBM) program to document all activitiesComplete all relevant paperwork following GDP/GMP guidelines.Perform routine cleaning of production rooms and equipment to maintain in GMP fashion.Perform sampling using aseptic techniquesParticipate on Continuous Improvement TeamsReceive and distribute supplies into production areas as necessary.Requirements:Knowledge of cGMP manufacturingKnowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems.Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.Must be able to read and follow detailed written instructions and have good verbal/written communication skills.Knowledge of basic chemical and biological safety procedures.Good computer skills, knowledge of Microsoft Word and Excel.Good interpersonal skills and be able to work effectively and efficiently in a team environment.This position requires shift, weekend and holiday work. Overtime may be required at times.The incumbent must work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.May require immunization before performing work within the manufacturing area.Qualifications:High school diploma or GED. 4+ years of related work experience or AA degree or higher and 2+ years related work experience.Train and mentor other team membersRevise and review pertinent documentation as appropriateAssist in troubleshooting process problems and responding to alarmsMay perform other duties as assigned Associated topics: bioengineering, biology, biomaterials, biomedical, biophysics, neurodegenerative, nutrition, pain, pathogenesis, therapeutic
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