Medical Device CSV Engineer - Data Integrity
Medical Device CSV Engineer (Data Integrity)
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.
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.
- Computer Systems Validation (CSV)
- Data Integrity
- 21 CFR Part 11
- cGMP - Laboratory Equipment (Chemistry or Micro)
Job Type: Contract