Medical Device CSV Engineer - Data Integrity
Medical Device CSV Engineer (Data Integrity)
Our client is a large Medical Device company currently looking to add a Computer Systems Validation (CSV) engineer to come in and help with a Data Integrity (DI) Remediation project. Recently had a third party auditor come in and do a gap assessment of their current systems.They will be executing a Computer System Validation (CSV)/Data Integrity gap assessment for analytical laboratory systems. Need candidates with experience in CSV/ DI and qualification of laboratory equipment/ systems.
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 with data integrity. This person will be doing risk assessments of all the systems. Work with Quality and the user community to create URS, Trace Matrices and Quality Plans. There is a separate team that will be doing the hands on validation, this person is responsible for more of the higher level and strategic thinking.
These individuals should have experience with data integrity principles, part 11 compliance, computer system validation, laboratory equipment qualifications, electronic records/signatures.
Must also have experience with qualification and operations in a research laboratory environment. Direct experience in the execution of validation protocols. Knowledge of current industry standards such as GAMP5 and part 11. They will primarily working with systems such as GC, LC, Mass Specs, and various other analytical instruments/ equipment.
- 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
- Laboratory Systems
Job Type: Contract