Shire Upstream Engineer in Lexington, Massachusetts
The Upstream Development Engineer, part of the PDTS (Process Development and Technical Services) organization, is responsible for providing providing technical and scientific support of downstream processes for commercial production and late stage clinical production of Biologics, including process and product investigations/troubleshooting, continuous process improvement and life-cycle management, technology transfer and process validation. This individual will contribute to various cross- functional teams and will interact extensively with other departments within Shire, including Manufacturing, PTS, QA, QC, PD, Engineering and RA etc.
The scope of the experimental work includes studies in support of process improvement ideas that may be implemented globally and are part of the project portfolio plan for the local Lexington, or any other global facility. Responsible for study design, execution, analysis and reporting under the guidance of senior staff.
Design and execute continuous process improvements, aimed at improving robustness, capacity, and productivity, as per Shire’s QbD paradigm. Provide technical expertise and leadership in identifying opportunities/areas, planning, designing and conducting experiments, analyzing data and documenting results towards continuous upstream process improvement, including reducing recurring deviations, and increasing level of safety and/or compliance.
Provide high quality of written study proposals, research and development reports, and investigation reports.
Provide technical expertise and leadership in trouble-shooting and root cause analysis for process discrepancies and quality investigations of complex technical nature
Implement effective and sustainable process control strategy including new Process and Analytical Technologies(PAT)
Education & Experience Requirements:
Minimum Degree Required: BS in a scientific or engineering discipline
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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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.