Vacancy caducado!
Process Development Engineer Providence, RI/Onsite role 6-12+ months
General Summary:Main key to role:- Med device experience followed by Pharma
- Validation / Process Development (IQ, OQ, PC, PQ)
- Custom equipment experience
- 8+ years of experience (5+ years with Masters) working on process development and optimization within a medical device environment or other GMP regulated industry.
- Experience leading and managing new process development initiatives from concept through execution, including process documentation and process qualification.
- Ability to coach and train less experienced engineers.
- Understanding of cGxP principles and practices and familiarization with ISO 13485, ISO 14971, and 21CFR820 is a plus. Knowledge of global cGMP requirements governing device or combination products.
- Experience with 3D CAD software, preferably with Solidworks, is preferred.
- A strong understanding of statistical principles is required, as are strong technical writing and presentation skills.
- Hands-on approach to problem solving, risk identification and resolution. Six-sigma Green Belt / DMAIC problem solving experience preferred.
- Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.
- Sense of urgency, ability to act/escalate promptly, and transparently communicate issues to involved stakeholders and management.
- Must demonstrate strong interpersonal, presentation, and teamwork skills.
Vacancy caducado!