VALIDATION ENGINEERS
Iselin, NJFull-time$130K/yrSeen todaySeen in employer's feed today
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Job overview
Manages specification, qualification and validation requirements, writes and executes engineering change orders, conducts risk‑based verification for GxP systems, creates and updates DFMEA for new implants and instruments, designs validation components and inspection plans, and performs inspection feature assessment.
Skills & qualifications
Skills
Qualifications
Full job description
Experience Required
60 MONTHS
Minimum Education Required
BACHELOR'S DEGREE
Compensation
$130,499.00 - $130,499.00 / Yearly
Hours Per Week
40
Number Of Positions
5
Shift
First Shift (Day)
Job Description
Manage specification, qualification and validation requirements. Write and execute engineering change orders related to Corrective and Preventive Actions (CAPAs), changes in Critical to Quality (CTQs), release of aging reports, updates to 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. Design, develop and oversee validation components and work on inspection plans and Inspection Feature Assessment. Skills required: Auto Cad, Matlab, Kaizen, Minitab, Tally, Catia, Python, Ansys and Gap Analysis. Bachelor’s degree in Science, Technology, Engineering, Mechanical Engineering, Industrial Engineering, or Biotechnology Engineering (any) along with five (05) years of experience in the job offered or related occupation is required. Work location: Iselin, NJ and various unanticipated locations throughout the U.S.
Email Resume to HR Dept., Intellectt, Inc., at [email protected]
Place of Work
On-site
Requisition ID
VE_576
Job Type
Full Time
Application Email
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