Shire Process Engineer - Technical Sevices Wet Lab in Social Circle, Georgia
Lead role in support of laboratory operations or manufacturing sciences. Maintain and manage laboratory operations, instrument qualification and maintenance as needed.
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.
Make sound technical recommendations and contribute to technical feasibility analysis regarding projects/matters.
Independently plan and execute a series of design and/or technical tasks that may not be well-defined, have multiple variables, and require advanced techniques within negotiated deadlines.
Devise new approaches to complex problems through adaptations and modifications of standard technical principles. Incorporate new methods and technologies for improving existing or new products/processes.
Evaluate results relative to protocol requirements, definitions and/or study goals. Provide analytical interpretation of result from studies to stakeholders.
Adhere to quality system, understand and apply applicable corporate, divisional and departmental procedures. Knowledge of related regulations and guidance (e.g., USP, ICH, and regional compendia) to facilitate compliance.
Requirements and e xperience:
The position requires relevant laboratory skills, writing skills, and computer skills plus teamwork/interpersonal skills.
Research lab experience may include research in GMP/QSR environment, cross-functional teamwork, and independent experimentation in method development and validation.
Strong working knowledge and expertise in the area of biochemistry, protein purification, and engineering principles
Experience in interacting with regulatory authorities and official bodies (FDA, EMA, etc.)
Experience in the management of small and medium projects
Knowledge of and appropriate compliance with guidelines as well as Shire internal requirements
Good knowledge of statistics and DOE principles
Knowledge of risk assessment tools
Bachelor's degree in a scientific/Engineering discipline with at least 3-5 years or MS with at least 1-3 years relevant experience, or equivalent.
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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.