VALIDATION ENGINEER

Shoolin Inc

Metuchen, NJFull-time$99K/yrSeen todaySeen in employer's feed today

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At a glance

Compensation

$99K/yr

Location

Metuchen, NJ

Schedule

Full-time

Work Authorization

Not specified

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Requirements

Credentials this posting asks for.

Master's degree

Job overview

Shoolin Inc seeks a Validation Engineer to design, develop, and oversee validation components using engineering and analysis tools. The role includes engineering change orders related to corrective and preventive actions, changes to critical-to-quality measures, and risk-based verification for GxP systems and laboratory equipment. The engineer also creates and updates failure mode and effects analyses for new implants and instruments.

Skills & qualifications

RequiredNice to have

Skills

AutoCADPythonMATLABKaizenMinitabTallyCATIAANSYSGap AnalysisValidationCorrective and Preventive ActionsGxP SystemsRisk-Based VerificationFailure Mode and Effects Analysis

Qualifications

Master's in Science, Technology, Engineering, Mechanical Engineering, Industrial Engineering, or Biotechnology Engineering

Full job description

Minimum Education Required

Masters

Compensation

$98,571.00 - $98,571.00 / Yearly

Hours Per Week

Number Of Positions

Shift

First Shift (Day)

Job Description

Design, develop and oversee validation components using AutoCAD, Python, Matlab, Kaizen, Minitab, Tally, Catia, Ansys and Gap Analysis. Write and execute engineering change orders related to Corrective and Preventive Actions (CAPA). Change in Critical to Quality (CTQs), release of aging reports and design history files. Conduct risk-based verification for GxP (GMP, GCP, and GLP) systems and laboratory equipment. Create, and update Failure Mode and Effect Analysis (DFMEA) for new implants and instruments. Master’s degree in Science, Technology, Engineering, Mechanical Engineering, Industrial Engineering, or Biotechnology Engineering (any) is required. Work location: Metuchen, NJ and various unanticipated locations throughout the U.S.

Email Resume to HR Dept., Shoolin, Inc., at [email protected]