There is a new automation line, it is developed, clients need someone to work on process development, validation, and run test equipment.
Roles and Responsibilities:
- Looking for a candidate with a background in mechanical or automation engineering.
- A working knowledge of the Bio-Pharmaceutical industry is beneficial.
- Possess experience with process development in a lean manufacturing area.
- Can write and execute protocols including installation qualifications (IQ), operational qualification (OQ) and performance qualification (PQ).
- In addition, they should have experience in composing work instructions and can provide guidance and training to others.
- Candidate should have experience working in a ISO-13485/9000 cGMP ISO 7 clean room environment.
- Candidate should have a strong work ethic that will drive results in an expeditious manner towards a positive outcome.
- Can collect and interpret data to develop capable manufacturing process that will yield a consistent quality product repeatedly.
- Additional skills in web converting/handling, heat sealing and system automation is a plus.
The 3 must haves are:
1. Process development
2. Validation Experience
3. Lean Manufacturing
- Medical Device
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