Medical Device CSV Engineer - Data Integrity

Charlotte, NC

Job ID: 129946 Industry: Med

 

Medical Device CSV Engineer (Data Integrity)

Project Description:

Our client is a large Medical Device company currently looking for someone to help conduct  Data Integrity Gap Assessments of Manufacturing and Laboratory systems to provide remediation actions for part 11 compliance. 

Work with a small team and define Validation requirements and documentation to be used for Application/System qualification. Develop protocol and unit/system test cases, scripts and plans. Facilitate testing activities within the team and across IT groups. Responsible for cross functional/ business integration testing and documentation. Understand and follow appropriate Software Development Life Cycle (SDLC) quality validation processes.

Responsibilities:

Our client is looking for individuals with strong Computer Systems Validation (CSV) background in the Medical Device or Pharmaceutical industries, minimum of 5 years of experience. These individuals should have experience with data integrity principles, computer system validation, equipment qualifications, HMI/PLC interfaces, electronic records/signatures.

Must have experience with qualification and operations in a cGMP environment within the laboratory. Direct experience in the execution of validation protocols. Knowledge of current industry standards such as GAMP5 and ASTM E2500.
  • Tactical thinker with experience working with testing, validation and/or quality strategies.
  • Excellent communication and documentation skills.
  • Good documentation / note taking skills & speaking skills.
  • Ability to understand and query where necessary to better understand current state.

 Required Skills:
  • Computer Systems Validation (CSV)
  • Data Integrity
  • 21 CFR Part 11
  • cGMP - Laboratory Equipment (Chemistry or Micro)
  • GAMP5 

Job Type: Contract   

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