Shire Senior Engineer I – Process Validation in Lexington, Massachusetts
The individual will be expected to provide process validation support for Shire biologics manufacturing operations located in Massachusetts, USA. The process validation activities related to the MA manufacturing site include, but are not limited to, the following areas:
Development of process validation protocols and other documentation for cell banking, cell culture and purification processes.
Execution of process validation studies, as well as data analysis and compilation of data and results into summary and final reports.
Provide technical assessments on change controls, deviations and investigations, assessing proposed changes to validated processes to identify requirements necessary to maintain validated status.
Own process validation related quality systems (CAPA, Change Control) and use project management skills to coordinate those project teams and drive results.
Participate in regulatory inspections.
Represent process validation team on project core teams and participate in strategy discussions on behalf of process validation in collaboration with PV strategy team and aligned with global PV and regulatory requirements.
Support and interface with global PPQ community of practice where needed to ensure alignment and consistency with global practices.
Write, execute, analyze results and summarize process validation activities in the following areas:
Tech transfer (new product introduction)
Continuous lifecycle management
Develop and assess the following Quality System elements for process Validation:
Quality Risk Management program
Participate and contribute in design, development, validation strategy, and routine GMP activities:
Provide technical input to strategy/philosophy for validation activities
Represent process validation during tech transfer activities as required.
Represent process validation during site GMP activities and participate on cross-functional teams
Own process validation Quality Systems, as required, and manage project through to closure per timelines
- Identify opportunities for continuous improvements, participate in the deployment of best practices, represent process validation at Lexington Site Work System meetings and support/maintain the process validation communications board and community of practice.
Participate in regulatory agency inspections for Process Validation.
Train other Shire staff on validation protocols.
Education & Experience Requirements:
- Bachelor's in Biology, Chemistry, Chemical Engineering or related field with a minimum of 8 years relevant experience or Master’s in related field with a minimum of 5 years relevant experience.
Other Job Requirements:
- The ability to work at all MA site locations as required. The person in this role will be required to carry an iPhone and be on call as required to support process validation activities.
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.