• Possesses strong organizational, multitasking, and Technical Writing abilities, with a solid background in manufacturing processes and controls
• Critically reviews, writes or revises various types of documentation to ensure completeness, accuracy, and compliance including but not limited to manufacturing records for batch and material release, specifications, validation protocols and summary reports, regulatory submissions, product complaints, annual product reviews, Quality Agreements, Supplier Notifications, Request For Proposals, SOPs, master plans, deviation investigations, CAPAs and change controls
• Assist and provide guidance on any nonconformance, deviation, or excursion that may occur, experience with deviations and CAPAs required
• Experience with Veeva and SAP preferred
• Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations, and standards
• Conduct risk assessments and provide a commissioning timeline of activities to identify and evaluate and prioritize risks associated with commissioning and qualifying
• Ability to work well independently and with minimum supervision and identify problematic deviations upfront
• Be able to help lead team in defining project strategies, developing goals, and ensures project scope is defined and controlled and requests outside the scope are identified within area of expertise 
• Be able to clearly communicate on expertise to internal and external teams when needed
• Some travel may be required

• Minimum 5 years previous experience with quality projects within the biotechnology and pharmaceutical industries
• Experience with commissioning and qualification of utilities (compressed air), growth direct system, equipment and CSV qualification of cell and gene therapy equipment required

Minimum of a Bachelor or equivalent discipline required

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