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Manufacturing Technician I

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 carts
  • Operate general production equipment (such as autoclave, COP washer, etc.)
  • Execute Electronic Batch Management (EBM) program to document all activities
  • Complete all relevant paperwork following GDP/GMP guidelines.
  • Perform routine cleaning of production rooms and equipment to maintain in GMP fashion.
  • Participate on Continuous Improvement Teams
  • Receive and distribute supplies into production areas as necessary.
  • Revise and review pertinent documentation as appropriate
  • Assist in troubleshooting process problems and responding to alarms
  • May perform other duties as assigned

Requirements:

  • Knowledge of cGMP manufacturing
  • Knowledge 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:

Requires High school diploma or GEDplus 1+ years ofrelated experience or AA or higher with no prior experience required and demonstrated knowledge of scientific principles.



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