Job Details

Validation Engineer

Responsibilities

The Validation Engineer will provide validation, technical, and compliance oversight for Cell Therapy and Viral Vector manufacturing and laboratory equipment throughout the full equipment lifecycle. This role will work with the Manufacturing, Quality Control, Analytical Development, Process Development, Quality Assurance, and IT departments to ensure equipment, systems, and processes are compliant with GMP and regulatory requirements. Responsibilities will include development of and execution of equipment qualifications, validation documentation, change control support, deviation investigations, and technical risk assessments to maintain equipment validated states. This role supports day-to-day operations, equipment qualification, preventive maintenance, and troubleshooting across all critical GMP departments, including such equipment as incubators, Biological Safety Cabinets, Lovos, Prodigies, and any new Cell Therapy equipment.

• Establish and maintain preventive and predictive maintenance programs while ensuring equipment remains in a validated and qualified state.
• Troubleshoot equipment issues, perform root cause analysis, and implement corrective and preventive actions (CAPA) in alignment with validation and quality requirements.
• Collaborate with external service providers to ensure maintenance and calibration activities comply with GMP and do not compromise equipment qualification status.
•  Update Maximo CMMS with accurate documentation of maintenance and qualification activities in accordance with data integrity principles.
• Author and execute IQ/OQ/PQ protocols and reports in compliance with GMP, FDA, and ICH guidelines.
• Partner with Quality, Validation, and Manufacturing teams to ensure equipment qualification documentation is accurate and audit ready.
• Manage equipment change controls including impact assessments on validated state and support for deviations and CAPAs.
• Train manufacturing and laboratory staff on proper equipment operation procedures, ensuring adherence to validated methods and GMP requirements.
• Ensure that changes, maintenance and other interventions are assessed for impact and do not compromise the validated/qualified state of equipment.
• Lead/support tech transfer of new equipment and unit operations with a focus on qualification, validation strategy, and lifecycle management.
• Provide technical oversight during development of equipment and Equipment system User Requirements Specifications (URS), Design Qualification (DQ), and related validation documentation.
• Provide guidance in development of test plans for Verification packages including risk-based validation approaches and critical component assessment.
• Provide guidance on key elements of return to service requirements including requalification and validation impact assessment after maintenance or interventions.
• Assist during internal and external audits, serving as validation SME and providing compliant documentation and technical justification.
• Assist and support routine maintenance activities, ensuring alignment with validated state requirements.
• Work cross functionally among Equipment Development, Manufacturing, Quality Control, Quality Assurance, IT to support full equipment lifecycle management from design through qualification and operation.
• Meet and report key performance indicators in alignment with Cell Therapy Manufacturing goals. 
• Identify opportunities to optimize equipment performance, reduce costs, and enhance reliability through innovative solutions and best practices.
• Perform other duties as assigned. 

Qualifications/Skills

• Bachelor’s degree in Engineering.
• 7+ yr’s. relevant experience, preferably in the biotech industry or equivalent combination of education and experience.
• Proficient with Microsoft Office: Word, Excel, Outlook and Teams.
• Experience in Equipment Development laboratory operations with various cell manufacturing platforms including closed systems for the development of T-cell therapy products.   
• Demonstrated ability to collaborate effectively in a multi-disciplinary team.  
• Demonstrated strong communication skills, interpersonal skills and a superior drive for results. 
• Excellent written, oral, interpersonal and presentation skills and the ability to effectively interface with senior management and staff. 
• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.  
• Previous experience with audits preferred.
• Meticulous attention to detail in terms of documentation and following SOPs. 
• Able to work a flexible schedule including nights, weekends, and holidays with short advance notice.