Senior Visual Inspection Process Engineer, MSAT Lead

Roche; Holly Springs (NC); On-site; USD 114,000 - 212,000; Full time

Benefits offered by this job

Relocation benefits

Job summary

F. Hoffmann-La Roche AG in Holly Springs, NC is seeking a Visual Inspection (VI) expert and Process Engineer to lead an end-to-end VI program in a highly automated greenfield facility.

You will collaborate with Manufacturing, Asset Engineering, Automation, and Quality Assurance to design, implement, and maintain an innovative VI process for commercial production. The role demands 8+ years in cGMP operations, deep VI expertise, and strong data-analysis skills, with a focus on regulatory readiness

Qualifications

• Bachelor’s or Master’s degree in Engineering, Pharmaceutical Sciences, or related field.
• 8+ years of experience in cGMP operations with demonstrated process improvements.
• Expertise with visual inspection systems (auto, semi-auto and manual) in a cGMP setting.
• Proficient in data analysis and statistical tools for process monitoring and optimization.
• Detail-oriented with strong analytical and problem-solving skills.
• Strong written and verbal communication and ability to lead cross-functional work.
• Ability to work independently, manage multiple projects, and drive change.
• Proven project management skills and capability to transfer technology to production.

Responsibilities

• Provide end-to-end VI program management for syringe and cartridge inspection.
• Serve as primary MSAT contact for VI and stay current with regulatory trends.
• Participate in process validation activities and defect/particulate management.
• Lead data gathering, root cause analysis, and process control changes.
• Support deviation investigations and corrective actions, with cross-functional teams.
• Contribute to technology transfer from development to commercial manufacturing.

Skills

cGMP operations

Process improvements

Visual inspection systems

Data analysis

Communication

Project management

Independent work

Education

Bachelor’s or Master’s degree

Job description

F. Hoffmann-La Roche AG in Holly Springs, NC is seeking a Visual Inspection (VI) expert and Process Engineer to lead an end-to-end VI program in a highly automated greenfield facility.

You will collaborate with Manufacturing, Asset Engineering, Automation, and Quality Assurance to design, implement, and maintain an innovative VI process for commercial production. The role demands 8+ years in cGMP operations, deep VI expertise, and strong data-analysis skills, with a focus on regulatory readiness