Sr. Validation Engineer

POSITION PROFILE: 

The Sr. Validation Engineer will provide specialized knowledge in developing the strategy for equipment qualifications and process validations. This includes products and processes for gene and cell therapy manufacturing.  Prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with impacted departments and personnel; oversees and reviews validation area processes and procedures. The Sr. Validation Engineer is responsible for the theory and content of validation documents for equipment, processes, systems, software, changes and on-going review and revalidation of said items to ensure that validation documentation is compliant with validation requirements and policies. Provides facility, equipment and process qualification technical expertise. Author validation documents and execute validations of equipment, control systems and production processes.  Oversee contractors or equipment vendor technicians during contracted validation/qualification activities.  Directs the life cycle of launched products to support development of manufacturing processes, drive right-first time metrics, and reduce product rejects. Coordinate and lead validations to assure compliance with regulatory requirements.

DUTIES AND RESPONSIBILITIES  

• Interface effectively with management personnel in IT, Operations, Quality, Manufacturing and other technical disciplines.
• Provide technical decision making regarding validation strategies and requirements for complex projects.
• Author and approve qualification plans, impact assessments, validation protocols, risk assessments, user requirement specifications, validation reports, and other documents supporting validation for new and existing manufacturing equipment and processes.
• Perform, coordinate and manage qualification testing including leading multifunctional project specific meetings
• Coordinate the Commissioning, IQ, OQ and PQ of all validation activities to assure compliance with regulatory requirements.
• Identify any areas for improvement and propose / implement approved necessary changes.
• Prepares, writes, and reviews validation protocols, reports, and other documentation to ensure compliance and adherence to Abeona’s SOP’s, product specifications, regulatory requirements and other applicable regulations.
• Review need for validation with equipment and process owners/SMEs
• Responsible for performing validation and managing large size validation projects and supervising technicians/contractors, providing necessary leadership and guidance.
• Responsible for the generation of protocols using a risk based approach that meets current regulatory requirements and industry practices.
• Responsible for managing to individual and team goals
• Performs other duties as assigned

QUALIFICATIONS (Education/Training, Experience and Certifications)

• BS degree in Engineering or Life Science (Chemistry, Bio, Physics, etc.)
• 10 years of experience in Equipment/Process Validation Engineering within a pharmaceutical or medical device company
• Experience qualifying process equipment and facilities in a pharmaceutical environment
• Experience in project management
• Experience validating building management systems, cleaning processes, and/or computer systems are preferred but not necessary.