Senior Principal Process Engineer, Visual Inspection (MSAT)
About The Position
Genentech is seeking a Visual Inspection (VI) expert to provide end-to-end VI program management for its highly automated greenfield drug product manufacturing facility in Holly Springs, North Carolina. The role will lead development of a compliant VI process, from kit building and Knapp studies through high-speed automated inspection, including automated eject inspection, and all steps in between. Working with a cross-functional team, the engineer will help build the program from the ground up and maintain and change-manage it through commercial production. The engineer will provide technical expertise for syringe and cartridge visual inspection operations, including manual, semi-automated, and automated inspection; serve as the primary VI contact for the Global MSAT network; participate in validation and technology transfer; and support investigations, process controls, continuous improvement, and regulatory inspections. The position works closely with Manufacturing, Asset Engineering, Automation, Quality Assurance, and the MSAT Lab. The role is fully onsite at the project office before transitioning to site offices. It may involve cleanroom work requiring gowning, and domestic and international travel of up to 20% after full relocation.
Requirements
- Bachelor's or master's degree in Engineering, Pharmaceutical Sciences, or a related technical field.
- At least 8 years of experience in cGMP operations.
- Strong knowledge of cGMP regulations and quality systems, with experience in a regulated environment.
- Demonstrated ability to implement process improvements.
- Expertise in automated, semi-automated, and manual visual inspection systems in a cGMP environment.
- Proficiency in data analysis and statistical tools for process monitoring and optimization.
- Strong analytical, detail-oriented, and problem-solving skills, including the ability to identify root causes and implement effective corrective actions.
- Strong written and verbal communication skills.
- Ability to work independently, challenge the status quo, manage multiple projects, prioritize and delegate effectively, adapt quickly, and collaborate on cross-functional teams.
- Demonstrated project management skills.
- Ability to work in an international or global environment.
- Ability to work onsite and, when required, in a cleanroom environment with gowning.
Nice To Haves
- Experience with qualification and validation protocols.
- Familiarity with Lean Six Sigma principles and continuous improvement methodologies.
Responsibilities
- Provide technical expertise and support for syringe and cartridge visual inspection operations, including process development, optimization, troubleshooting, and improvement initiatives.
- Provide technical support for manual, semi-automated, and automated drug product visual inspection operations.
- Serve as the primary point of contact for visual inspection to the Global MSAT network.
- Keep current with regulatory and industry trends in visual inspection.
- Participate in process validation activities.
- Design reject material classifications, trending, and response.
- Assist the MSAT Lab in designing the particulate management program and defect libraries.
- Defend the overall visual inspection program during regulatory inspections, including Pre-Approval Inspections.
- Gather data, perform root cause analyses, and trend performance to develop process control changes for complex issues.
- Support deviation investigations and root cause analyses from product impact and process perspectives.
- Recommend and support implementation of corrective and preventive actions.
- Participate in product complaint assessments or investigations and related post-market surveillance activities as needed.
- Use Lean Production System elements and methods to continuously improve tactical business processes and procedures.
- Participate in technology transfer from development to commercial manufacturing, ensuring successful scale-up and process validation.
Benefits
- Relocation benefits are provided.
- A discretionary annual bonus may be available based on individual and Company performance.
- The position qualifies for benefits detailed at the linked benefits page.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
