Sr. MS&T Process Engineer II

Responsibilities

• Act as key technical lead for process development.
• Independently design and manage studies for process development, process optimization, scale-up, manufacturing records and technology transfer.
• Serve as the technical lead for sterile injectable visual inspection, assembly, labeling, and packaging process validation activities, including equipment qualification support, process characterization, and continued process verification.
• Independently design studies for evaluating the robustness of the manufacturing process.
• Provide technical oversight and support for manual and automated visual inspection processes, including defect library development, inspection qualification studies, AQL implementation, false reject analysis, and continuous process improvement initiatives.
• Lead technology transfer activities for inspection, assembly, and packaging operations from clients and development sites into commercial manufacturing, ensuring successful process implementation and regulatory compliance.
• Develop and execute process validation strategies for inspection, assembly, labeling, cartoning, serialization, aggregation, and secondary packaging processes in accordance with FDA, EU GMP, and client requirements.
• Author and review protocols, reports, risk assessments, manufacturing instructions, and validation documentation supporting packaging and inspection equipment, processes, and technology transfers.
• Perform statistical analysis and trending of inspection and packaging process performance data to identify opportunities for process optimization, defect reduction, yield improvement, and enhanced operational efficiency.
• Support deviation investigations, CAPAs, change controls, nonconformance evaluations, and root cause investigations associated with inspection, assembly, and packaging operations.
• Collaborate with Manufacturing, Quality Assurance, Engineering, Supply Chain, Validation, and Regulatory Affairs teams to ensure successful execution of clinical and commercial packaging programs.
• Represents MS&T department as subject matter expert routinely in meetings/conference calls with clients.
• Works with client’s lead technical staff, department management and senior management to evaluate complex technical details pertaining to the project and defines the scope of the project.
• Function as the Subject Matter Expert (SME) for Manufacturing processes and Technical Transfer of new products in regard to process development.
• Execute experiments to support the development and characterization of new manufacturing processes.
• Makes recommendations to the business development team regarding pricing and project studies and assist in preparation of project proposals.
• Support implementation and lifecycle management of Continued Process Verification (CPV) programs for inspection, assembly, and packaging processes through monitoring, trending, and periodic product reviews.
• Provide technical guidance and training to manufacturing personnel on inspection standards, packaging processes, defect identification, process controls, and new product introductions.
• Support client audits, regulatory inspections, and customer technical discussions related to sterile injectable inspection, assembly, and packaging operations.

Qualifications

• SITE B.S. in Science or Engineering
• 7+ years of equivalent job experience
• Strong leadership skills; high level of personal/departmental accountability and responsibility
• Strong understanding of process design principles
• Experience with drug product manufacturing processes development, process scale-up and optimization
• Ability to perform well under tight timelines and excellent decision-making quality under pressure is desired
• Ability to manage multiple priorities and tasks in a dynamic environment
• Experience supporting sterile injectable visual inspection, assembly, labeling, and packaging operations in a pharmaceutical manufacturing or CDMO environment
• Knowledge of automated and manual visual inspection systems, defect classification, AQL methodologies, and inspection qualification requirements
• Experience with technology transfer, process validation (PPQ), CPV, and equipment qualification activities associated with packaging and inspection operations
• Familiarity with serialization, aggregation, labeling compliance, and secondary packaging requirements for commercial pharmaceutical products
• Strong understanding of FDA, EU GMP, Annex 1, and industry expectations related to sterile injectable inspection and packaging processes