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)
- Change management
- Continuous lifecycle management
Develop and assess the following Quality System elements for process Validation:
- Quality Risk Management program
- Change Controls
- GMP Investigations
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.
Location/Region: Lexington, MA