Senior Principal Process Engineer, Visual Inspection (MSAT)

The Opportunity

We are seeking a Visual Inspection (VI) expert with a focus on providing end to end VI program management. As a Process Engineer, you will play a crucial role in developing a compliant end to end VI process from kit building and Knapp to high-speed automated inspection (including automated eject inspection) and all steps in-between. This opportunity is to provide VI program leadership in a highly automated greenfield facility and develop with a cross-functional team the program from the ground up.

As a member of this team, you will work closely with Manufacturing, Asset Engineering, Automation, and Quality Assurance, to develop an innovative and highly automated VI process and then maintain and change manage that process into commercial production.

• Provide technical expertise and support for visual Inspection operations (syringe and cartridge), including process development, optimization, troubleshooting, and improvement initiatives
• Provide technical support and expertise for drug product manual visual inspection, semi-automated Inspection, and automated inspection operations
• Act as primary point of contact to the Global MSAT network for VI
• Keep up on regulatory and industry trends in VI
• Participate in process validation activities
• Design reject material classifications, trending, and response
• Assist with MSAT Lab in design of particulate management program and defect libraries
• Defend overall VI program in regulatory inspections in Pre-Approval Inspections
• Perform data gathering, root cause analysis, and performance trending to develop appropriate process control changes for complex issues
• Support deviation investigations and root cause analyses from a product impact and process perspective
• Recommend and support implementing corrective and preventive actions as necessary
• Participate in product complaint assessments and or investigations, and other related post-market surveillance activities as needed
• Utilize Lean Production System elements and methods to continuously improve tactical business processes and procedures
• Participate in technology transfer activities from development to commercial manufacturing, ensuring successful scale-up and process validation

Who you are

• Bachelor's or Masters degree in Engineering, Pharmaceutical Sciences, or a related technical field and 8+ years of experience in cGMP operations
• Strong knowledge of cGMP regulations and quality systems, with experience working in a regulated environment
• Proven ability to implement process improvements
• Recognized as an expert with visual inspection systems, including automated, semi-automated, and manual processes in a cGMP environment
• Proficient in data analysis and statistical tools for process monitoring and optimization
• Detail-oriented with strong analytical and problem-solving skills, with the ability to identify root causes and implement effective corrective actions
• Strong written and verbal communication
• Ability to work independently and challenge the status quo, handle multiple projects, prioritize and delegate effectively, adapt to changes quickly, and work collaboratively on cross-functional teams
• Demonstrated project management skills

Preferred

• Experience with qualification and validation protocols
• Familiarity with Lean Six Sigma principles and continuous improvement methodologies

Work Environment/Safety Considerations

This role requires full onsite work at the project office before transitioning to the site offices. Ability to work in an international/global environment. Domestic and international travel required. Travel up to 20% after full relocation. May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves, and steel toe boots.