Shire Production Engineer II, IG 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 Production Engineer II, Ig is responsible for on-shift operational support of the IG Purification process

Primary responsibilities of this role include:

  • Troubleshoot and provide timely resolution to technical issues in support of ramp-up and steady-state operations of a highly-automated pharmaceutical manufacturing facility. Scope of support will include:

  • IG Purification process anomalies

  • Process equipment (Vessels, Chromatography Skids, UF/DF filtration, Nano Filtration, Sterile Filtration, COP washers, CIP skids, )

  • Distributed Control System (DeltaV) and Process Logic Controllers

  • Manufacturing Execution System (Siemens Simatic IT)

  • Automation hardware

  • In Process Testing lab (pH, conductivity, TPUV)

  • Safety and quality investigations

  • Continuously improve manufacturing operations by:

  • Reducing manufacturing events, user interventions, and batch record alerts

  • Identifying and developing opportunities to reduce cycle time, error proof operations, and eliminate waste

  • Performing operational assessments to ensure proper processes, procedures, tools, and training are in place

  • Investigating and resolving issues assigned from the departmental issues log

  • Supporting Process Unit Team projects and Continuous Improvement efforts

  • Actively support information sharing and learning between team members by:

  • Lead Knowledge Transfer training with manufacturing staff

  • Coach manufacturing staff while partnering with them to resolve technical issues

  • Develop troubleshooting guides for common problems

  • Share process knowledge with colleagues across-shift

Requirements:

Education

B.S. degree in an engineering or scientific discipline (Chemical Engineering preferred)

Experience

Minimum of 2 to 6 years of related work experience, preferably within a GMP environment

Engineering Knowledge

Experience with basic engineering principles in various engineering disciplines

Problem Solving

Ability to solve routine engineering problems without assistance

Communication

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

Lean/Six Sigma

Training in concepts of Lean Manufacturing and Six Sigma quality techniques is preferred

Collaboration

Ability to lead small teams and work as a collaborative team member

Training

Ability to train other engineers on specific topics

Travel

Ability to travel on an infrequent basis (< 5 %)

Schedule

Ability to work 12 hour shift, including nights, weekends, and holidays in support of a 24 x 7 manufacturing operation

Drive

Self-driven individual that requires minimal supervision

Miscellaneous

Ability to work in a clean room environment

Ability to wear personal protective equipment (such as hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

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.