This individual will be responsible for providing senior level support of the QA Validation functions for the Massachusetts Biologics Operations with primary support at the Alewife Cambridge location. This is a senior individual contributor role with primary responsibility for supporting engineering and validation programs and projects, Capital projects, technology transfer, and supporting any cross-site Facilities/Engineering/Validation initiatives.
Provide quality oversight and ensuring GMP compliance for engineering and validation deliverables related to site and capital projects (Compliance, Improvement, Technology Transfers, etc.) including requirements definition, specification, engineering design, qualification, process validation and change management
Serve as point of contact for customer groups to identify project needs and ensure practices are consistent with quality and regulator standards
Support site validation maintenance and remediation activities
Providing support during internal and agency inspections, Annual Product Quality Review and performing quality assessment for all site based engineering changes
Develop and maintain good working relationships with customer groups and support an environment of teamwork and collaboration
Education and Experience Requirements:
- 5+ years of industry experience in a pharmaceutical/biotech GMP environment
- BS in Engineering and or Science and a minimum of 3 years of project management and or project support experience with increasing responsibility in the areas of Quality Assurance
- Knowledge of FDA and EMEA regulations, process validation, and a working knowledge of statistical analysis and root cause analysis is required
- Knowledge of plant utility and equipment systems from the QA support perspective
- Exposure and/or knowledge of ICQ and Engineering functions
- Ability to create, manage and improve complex Quality systems, integrating with existing systems
- Proficiency with Microsoft applications including Word, Excel, Project, and Powerpoint; ability to learn additional software applications such as Trackwise and Veeva, LIMs experience a plus
Other Job Requirements:
Car required for local travel between Shire Lexington plants. Weekend and off hours work may be required.
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