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 Senior Principal Production Engineer bumin & Fractionation is responsible for operational support of the Albumin and Fractionation departments in Covington, GA. The position utilizes engineering and project management skills to align process and teams to resolve complex manufacturing problems. The position focuses on accelerating the timeline to achieve full production rate.

Primary responsibilities of this role include:

• Supporting ramp-up and steady-state operations of two highly-automated pharmaceutical manufacturing facilities. Scope of support will include:

• Plasma Fractionation and Albumin Purification processes
• Process equipment (vessels, centrifuges, filter presses, UF/DF, robotics, 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, titration)
• Safety and quality investigations
• Continuously improving manufacturing operations by:

• Reducing manufacturing events, user interventions, and batch record alerts
• Identifying opportunities and delivering projects to reduce cycle time, error proof operations, and eliminate waste
• Performing operational assessments to ensure proper processes, procedures, tools, and training are in place
• Developing Process Unit Team initiatives and leading Continuous Improvement efforts
• Eliminating manufacturing challenges through ownership of departmental issues logs
• Refining and implementing vision for Electronic Batch Management (EBM)
• Training, coaching, and mentoring on-shift Production Engineers
• Actively supporting information sharing and learning between team members by:

• Leading Knowledge Transfer training with manufacturing and engineering staff
• Coaching manufacturing staff while partnering with them to resolve technical issues
• Developing troubleshooting guides for common problems
• Sharing process knowledge with colleagues across-shift

Requirements:

• B.S. degree in an engineering or scientific discipline (Chemical or Mechanical Engineering preferred)
• Minimum of 8 to 12 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 without assistance
• Ability to discuss complex technical and project management issues, both verbally and in written form
• Ability to lead cross-functional teams, exert broad influence, and work as a collaborative team member
• Self-driven individual that requires minimal supervision
• Training, demonstration, and leadership of concepts of Lean Manufacturing and Six Sigma quality techniques is preferred
• Ability to flex work schedule and take call as required to support manufacturing operations and project needs
• 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
• Ability to travel on an infrequent basis (

5 %)

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shirealent 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.

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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.