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. Has responsibility for self-identification of process optimization opportunities, and detailed assessment of opportunities (process risk, financial cost/benefits, etc.). Participates in cross-functional assessments, as required to evaluate optimization opportunities/issues. Coordinate and lead validations to assure compliance with regulatory requirements.

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 large scale and complex projects.

• Create Standard Operating Procedures and training materials.

• 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.

• 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 and 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, method and process owners/SMEs

• Responsible for performing validation and managing large size validation projects and supervising technicians/engineers/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

• Train staff in the execution of Qualification and Validation Protocols and results reporting

• Ensure controlled documents are reviewed and maintained within the company Document Control system.

• Assist in FDA and other regulatory agency inspections.

• Assist in daily operational issues, as needed.

• Enhance skills via regular training and continuing education

• Performs other duties as assigned

  Requirements

• Bachelor’s degree in engineering or Life Science (Chemistry, Bio, Physics, etc.) 

• 8+ years of experience in an Equipment and/or Process Validation Engineering role within a pharmaceutical or medical device company 

• Must be easily adaptable to changing priorities and deadlines, be well organized, articulate, and possess good writing skills.

• Experience qualifying process equipment and facilities in a pharmaceutical environment

• Experience in validating formulation and filling processes in a cleanroom environment

• Working knowledge of GLP, GDP, GCP and GMP regulations and their relevant ISO counterparts.

• Knowledge of software packages supporting statistical data analysis, word processing, flow charting, and project management.

• Familiarity and understanding of manufacturing equipment and methods related to the production of gene and cell therapy related products.

• Familiarity with calibration and preventive maintenance requirements

• Use of computers and peripherals related to validation execution and document authoring.

• Strong communication skills, both verbal and written; ability to work and interface with all levels of the organization.

• Ability to work independently and as a team member, as well as, with Consultants/Contractors to achieve projects' validation objectives.

• Ability to analyze, investigate and propose approaches to technical and regulatory issues.

• Ability to design, execute and analyze manufacturing process validation studies.

• Ability to manage multiple concurrent tasks/studies.

• Ability to execute the Qualification Plans for gene and cell therapy and related product manufacturing equipment and facilities.

Powered by JazzHR