Genentech
Senior Principal Process Engineer, Visual Inspection (MSAT)
Holly Springs, USA · Principal
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About the role
- We are seeking a Visual Inspection (VI) expert with a focus on providing end to end VI program management.
- You will act as primary point of contact to the Global MSAT network for VI
- You will keep up on regulatory and industry trends in VI
Responsibilities
- 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.
- You will provide technical expertise and support for visual Inspection operations (syringe and cartridge), including process development, optimization, troubleshooting, and improvement initiatives
- You will provide technical support and expertise for drug product manual visual inspection, semi-automated Inspection, and automated inspection operations
- You will design reject material classifications, trending, and response
- You will assist with MSAT Lab in design of particulate management program and defect libraries.
- You will perform data gathering, root cause analysis, and performance trending to develop appropriate process control changes for complex issues
- You will support deviation investigations and root cause analyses from a product impact and process perspective
- You will recommend and support implementing corrective and preventive actions as necessary.
Requirements
- You have a Bachelor's or Masters degree in Engineering, Pharmaceutical Sciences, or a related technical field and 8+ years of experience in cGMP operations
- You have strong knowledge of cGMP regulations and quality systems, with experience working in a regulated environment
- You are recognized as an expert with visual inspection systems, including automated, semi-automated, and manual processes in a cGMP environment
- You are proficient in data analysis and statistical tools for process monitoring and optimization.
- You have strong written and verbal communication
- You have an 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
- You have a demonstrated project management skills
- You have experience with qualification and validation protocols
- You have familiarity with Lean Six Sigma principles and continuous improvement methodologies
- Ability to work in an international/global environment.
Compensation
- The expected salary range for this position based on the primary location for this position of Holly Springs, NC $114,400 - $212,400 Actual pay will be determined based on experience, level, qualifications, geographic location, and other jo
Company info
- The Opportunity: We are seeking a Visual Inspection (VI) expert with a focus on providing end to end VI program management.
This listing is sourced directly from Genentech's careers page and normalized into a canonical job model.