CSV Equipment Qualification Engineer in Beaverton, MI at Johnson Service Group

Date Posted: 11/17/2020

Job Snapshot

Job Description

JobID: 380926

A validation and quality assurance provider are looking to hire a CSV Equipment Validation Engineer for their Beaverton, Michigan project site. This unique group works to develop and blueprint a universally implemented validation process that reliably achieves quality, affordable and available healthcare products

This assignment is approved for 1 year with the potential of being extended or going direct. The hourly rate is $50.00 to $55.00

Summary

Creates and executes project plans, Change Control Documents, Risk Assessments, User Requirements Specifications, Functional Design Specifications, Validation Plans, Validation/Qualification Protocols, Traceability Matrix, SOPs and every required documents and records for projects and day to day business.  Coordinate the proper test methods for single use assemblies.  Responsible for conducting testing and initiating statistical analysis of process test results.

REQUIRED QUALIFICATIONS

  • Bachelor’s Degree in Engineering, Sciences or related field required.
  • 5+ years’ experience in Quality/Validation within biopharma or medical devices manufacturing required.  Commitment to Quality Assurance and compliance.  Follow SOPs and industry best practices, able to adequately canalize possible gaps in meeting regulation standards if required.
  • Solid knowledge and experience in pharmaceutical/medical devices projects, commissioning, qualification and validation life cycle applying adequately CGMPs and GDPs.
  • Skilled in Microsoft Office and QAD or similar manufacturing software.  Knowledge on USP and ISO standards for medical and biopharma industry.
  • Ability to work well with ever changing priorities and/or situations.
  • High level of technical knowledge for custom manufacturing processing, which includes BOM, product structures and fixtures.
  • Particulate and Bioburden, Endotoxin and Sterility knowledge preferred.
  • CQA-Certified Quality Auditor preferred.
  • RAPS-Regulatory Affairs Professional preferred.
  • Strong critical thinking to analyze complex situations and discern critical issues.
  • Excellent team player attitude.
  • Strong sense of ethics and prefers to work in an environment of total respect to every individual.

JSG is a leading staffing agency specializing in a variety of industries. Having been named to three Staffing Industry Analysts (SIA) lists for the third year in a row, JSG continues to grow and offer hiring solutions to companies across the United States.  JSG serves both busy recruiters and qualified candidates within multiple industries from our major offices headquartered in Chicago and Atlanta with local offices throughout the United States and Canada.

Please email resume to Allen Mudalel  amudalel@jsginc.com




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