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Sr. Engineer - IG Production Engineering

Job 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 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 Sr Engineer IG Production Engineering is responsible for on-shift operational support of the IG Purification process and to support ramp up activities.
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 Work cross functionally in the department to support Aseptic Filling operations as needed.
B.
S.
degree in an engineering or scientific discipline (Chemical Engineering preferred) Minimum of 5 to 10 years of related work experience, preferably within a GMP environment Experience with basic engineering principles in various engineering disciplines Ability to solve complex engineering problems with minimal or no assistance Ability to discuss complex technical and normally encountered project management issues, both verbally and in written form Training and demonstration of concepts of Lean Manufacturing and Six Sigma quality techniques is preferred Ability to lead teams, influence, and work as a collaborative team member Ability to travel on an infrequent basis (< 5 %) Ability to flex work schedule and take off-hours call as required to support manufacturing operations and project needs Self-driven individual that requires minimal supervision 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

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