Senior Manufacturing Automation Engineer, GMP
This position will join the Company Operations team to manage automation and process control projects with contract manufacturers for company products. This individual will work closely with internal functional teams as well as counterparts from the contract manufacturers (CM) to develop and qualify automation, fixtures and data transfer tools required to manufacture company products.
- Assume primary responsibility for managing the CM in developing equipment and tools required for the company production processes
- Work with company operations engineer, functional teams and the CM to lay out a scale up plan to meet short and long term manufacturing volume goals
- Work with the CM to ensure specifications meet company quality and volumes objectives for production
- Review and provide detailed input to the CM on tooling and equipment at the concept and final design phases of the project
- Ensure all engineering specifications, test and qualification documents are complete and archived in company repositories.
- Also be responsible for development or procurement of tools and equipment necessary for internal manufacturing processes at the company
- Complete design specifications and documentation for the internal projects including reviews with internal functional groups
- Develop manufacturing data transfer tools to stream IPQC and FQC information back to the company for process tracking
- BS or MS in Engineering with 5+ years of engineering experience with high volume manufacturing, 3+ years for the life science or medical device industry
- Experience working in GMP environment and 21 CFR 820 Quality System Regulations
- Travel and extended presence at CM facilities will be required for some projects
- Direct design experience in robotics, automatic controls, precision motion control, optical inspection and manufacturing database systems is required
- Direct experience developing manufacturing database & data transfer tools with Python and postgreSQL
- Demonstrated experience with technology transfer from product development to manufacturing engineering and operations
- Demonstrated experience managing CMs for major capital projects
- Excellent verbal and written communication skills is essential
- Knowledgeable and proficient working with PLM systems, developing schedules, BOM management, change orders and document control.
- Proficient skills with Solidworks and EPDM
- Experience working with SPC analytical tools and statistical analysis using Minitab