Shire Manufacturing Tech II / Plasma Warehouse in Social Circle, Georgia

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.

Responsible for the Receiving, Dispositioning, and Storage of Human Blood Plasma.

Expected to demonstrate skills of Manufacturing Associate I.

  • Process understanding of primary work areas (e.g. Buffer preparation, fractionation,

purification, fill, finish).

  • Troubleshoot and identify atypical processing conditions and how to respond to them.

  • Provide a moderate level of troubleshooting, diagnostic, and assist with repair of criticalequipment including but not limited to; Roller Thaw, Teardown Machine, Filter Presses,

  • Centrifuges, Precipitate Vessels and CIP/COP systems. May also include simple preventive maintenance tasks. Train others and explain process to others.

  • Work with other departments to ensure adherence to production schedule.

  • Basic Knowledge of Delta V, PLC based process control systems. Human Machine Interface(HMI) configuration.

  • Basic Knowledge of instrumentation and mechanical equipment such as controllers, indicators,control valves, PLC, analyzers, sensors, pumps etc.

  • Maintain inventory and disposition plasma to production runs for the Fractionation department.

  • Responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations, which could apply.

  • Participate in both departmental projects and any quality working teams which may be applicable.

  • Responsible for keeping and updated record of training, including new revision on Standard Operation Procedures (SOP’s) as well as any other training that is required for the department.

  • Perform basic and/or complex trouble shooting tasks for the Plasma Sorting Line. Organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills.

Essential Duties & Responsibilities:

  • Supports all local Manufacturing Plasma Operations

  • Receive physically and electronically plasma shipments

  • Main responsibility is the Automated and Manual Disposition of plasma units based on the teardown schedule

  • Help with the staging of disposition plasma to be delivered to production

  • Segregate questionable plasma units found in any area of the +5 degree C area and -20 degree C area to be process as “On Hold” or “Quarantine” status.

  • Operate material handling equipment (such as forklifts and pallet-jack).

  • Complete relevant paperwork following GDP/GMP guidelines and operate in compliance with FDA, OSHA AND MSDS.

  • Participate on Continuous Improvement Teams,.

  • Perform daily cleaning of the production area to maintain in GMP fashion.

  • May perform other duties as assigned.

Experience in a regulated production

environment desirable:

 Bachelor’s degree or

 AA or equivalent and 1+ years of

experience or

 High School diploma with 3+ years of

experience.

Must have working knowledge of

scientific principles. Scientific or

technical degree preferred.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

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.