Shire Manufacturing Associate II 30296 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. The position will support the development of a new, state-of-the-art plasma processing facility that will bring Shire additional cGMP capacity for fractionation, purification, filling, and packaging for its biologic medications.

The Manufacturing Associate II position is responsible for executing all fill finish and validation activities in addition to other facility start-up support activities. The role will then transition to an operational manufacturing shift associate position where it is expected that the incumbent executes all manufacturing department processes in production while strictly adhering to cGMP, environmental health and safety guidelines, and any other related regulation which could apply. This position is expected to demonstrate skills of the Manufacturing Associate II, which include: developing a process understanding of primary work areas (Filling, Vial Washer, COP, SIP, Autoclaving and Palletizing, etc.). Execute activities on manufacturing floor in accordance with schedule; involves effective communication and working with other departments. Troubleshoot and identify atypical processing conditions and how to respond to them. Provide a moderate level of troubleshooting and diagnosis and assist with repair of departmental equipment and systems as needed; may include executing simple preventive maintenance tasks. The incumbent must have basic knowledge of Delta V, PLC-based process control systems and Human-Machine Interface (HMI) configuration. Basic knowledge of instrumentation and mechanical systems such as controllers, indicators, analyzers, control valves, sensors, etc. Contribute to a culture of safety first in compliance with Environmental, Health, and Safety (EHS) guidelines. Understand and follow Job Hazard Analysis (JHA) packets. Ensure execution of processes in production while strictly adhering to all regulations which could apply.

In addition, the Manufacturing Associate II is expected to:

  • Ensure timely and accurate generation of process documentation, and review documentation

  • Train and mentor others on complex processes

  • Must be customer focused and exhibit leadership attitude

  • Take ownership of any issue

  • Assemble and operate filtration systems

  • Monitor and record critical process parameters

  • Complete all relevant paperwork following GDP/GMP guidelines

  • Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion

  • Perform sampling using aseptic techniques

  • Practice Continuous Improvement

  • Write, revise and review pertinent documentation as appropriate

  • Troubleshoot process problems and respond to process alarms

  • Assist with process/equipment validation and data analysis

  • Work with other groups such as maintenance/metrology to ensure preventative maintenance is done

  • 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 experienceMust 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.