Medical Device Data Integrity Project Manager
Medical Device Data Integrity PM
Our client is a large Medical Device company currently looking to add a Project Manager to their tech operations group. They will be overseeing Computer System Validation (CSV)/Data Integrity (DI) gap assessment for lab and manufacturing systems. Need a candidate with experience in CSV or DI and qualification of laboratory equipment. The assessment must be completed by the end of the year.
Our client is looking for a PM with strong Computer Systems Validation (CSV) background in the Medical Device or Pharmaceutical industries, minimum of 5 years of experience. This individual should have experience with data integrity principles, computer system validation, equipment qualifications, HMI/PLC interfaces, electronic records/signatures.
Must have experience with with project management, overseeing the 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.
- Project Management
- Computer Systems Validation (CSV)
- Data Integrity
- 21 CFR Part 11
- cGMP - Laboratory Equipment (Chemistry or Micro)
Job Type: Contact