| Validation Process Engineer || Providence, Rhode Island - ONSITE || No H1 at Providence, Utah, USA |
| Email: [email protected] |
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From: Kaveri, Tek Pyramids [email protected] Reply to: [email protected] Title :: PROCESS ENGINEER Location :: Providence, Rhode Island - ONSITE Duration :: 12-18 + Months MOI :: Video Visa :: NO H1B - Experience in DEVELOPING Processes from scratch !!!! The candidate will be drilled on this in the interview and will be asked " How the did that process & why" - Ideally, a candidate that has" Medical Device" experience. - MANUFACTURING Environment experience - GMP Required Qualifications: BS or MS in engineering or another relevant discipline. 5+ years of experience (3+ 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 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. Keywords: microsoft Validation Process Engineer || Providence, Rhode Island - ONSITE || No H1 [email protected] |
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| 10:01 PM 30-Apr-24 |