As Automation Engineer, you will ensure that all automated manufacturing processes have alignment with the validation strategies and quality procedures, assist in the development of vision and programming standards and source code reviews for automated equipment, and provide guidance to suppliers on new equipment builds, analyze production equipment performance and develop plans to increase yield from underperforming inspections.
Requirements
- 2+ years of experience in Automated Manufacturing
- Validation experience, process and equipment qualification (IQ,OQ,PQ), Test Methods
- Compose professional documentation (Write protocols, work instructions, engineering studies, etc.)
- Manage time and projects effectively while setting and meeting ambitious schedules
- Knowledgeable on regulatory requirements, FDA 21 CFR 820/GMP Medical Device Regulations
- Working knowledge of Minitab
- Knowledge of statistical techniques and sampling for process validation and process monitoring is desired
Benefits
- 3 weeks of PTO starting your 1st year in addition to 10 paid holidays
- Potential for annual profit sharing bonus based on company performance
- Major health, dental, vision, and complementary insurances offered starting day 1
- 50% match on your first 6% of 401k contribution with opportunity for an employer contribution annually