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.
Lead execution of robust technology transfer strategies for successful, on-time commercial plant start-up.
Support commercial manufacturing operations to meet fulfillment targets (lot release timing). Complete CAPA tasks to ensure on time release of lots; product impact assessments, corrective and preventive actions and root cause investigations as needed.
Act independently with minimal supervision to initiate and/or conduct studies and improvement projects for product quality, process robustness, product yield and cycle time based on recent technical knowledge.
Identify and fulfill documentation requirements that support product licensing approvals.
Approve protocols and support documentation in order to support regulatory licensure of the facility.
Understand and integrate information from multiple disciplines and apply it to solving complex problems using Lean/Six Sigma and related variation reduction techniques. Requirements: Education and/or Experience
Education and/or experience:
- Knowledge of the basic principles in various engineering disciplines
- Should have initial training in concepts of "Six Sigma" quality techniques.
- Knowledge of GMPs, FDA guidelines and process validation.
- Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.
- DeltaV Process Control system familiarity a plus.
BS in Engineering (Chemical preferred). 0 - 4 years' experience