Shire Engineer I / II in Social Circle, Georgia

Description:

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 Ophthalmic.

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 Production Engineer I/II is responsible for operational support of the Plasma Fractionation and Albumin departments.

  • Drive all operational deliverables to ensure successful start-up, including:

  • Author SOPs, training materials, Electronic Batch Management (EBM) process steps, and manufacturing risk assessments

  • Specify raw material bill of materials and drive onboarding of those materials along with proposed incoming analytical testing

  • Specify production work order builds for materials resource planning system

  • Specify process analytical requirements for Laboratory Information System (LIMS) builds

  • Ensure availability of all materials and consumables

  • Determine Environmental, Health, and Safety (EHS) needs and risks

  • Support design and qualification of manufacturing facility and equipment, including:

  • Review automation functional requirement specifications, detailed design specifications, alarming requirements, and graphic builds

  • Review validation protocols; execute factory acceptance testing and other qualification activities together with process engineering and validation teams; support deviation investigations for root cause and corrective actions

  • Own user requirement specifications (URS) for lifecycle management of equipment

  • Actively participate in technology transfer:

  • Participate in process comparison / gap analysis for Fractionation Department and propose mitigations

  • Liaise with counterpart(s) at sending site(s) to accelerate knowledge transfer

  • Act independently with minimal supervision to conduct engineering assignments of approved projects. Expected to make suggestions on improvements based on recent technical knowledge and experience.

  • Ability to solve routine engineering tasks and manage small projects with minimal assistance.

  • Responsible for organizing data and preparing appropriate documentation, including presentation materials, for assigned projects

Requirements:

  • Knowledge of the basic principles in various engineering disciplines

  • Self-driven individual that requires minimal supervision

  • Ability to discuss normally encountered technical or project management issues, both verbally and in written form

  • Ability to work as a collaborative team member

  • Ability to solve routine engineering problems with minimal assistance

  • Ability to travel and spend training time at sending sites

  • Ability to work on shift, including nights, weekends, and holidays in support of a 24 x 7 manufacturing operation

  • B.S. degree in an engineering discipline (Chemical Engineering preferred), with a minimum of 0 to 6 years of related work experience within a GMP environment.

  • Initial training in concepts of Lean Manufacturing and Six Sigma quality techniques is 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.