Direct W2 employee only! No 3rd party agencies!
Job Title: Validation Engineer
Our client seeks validation consultants with experience in a GxP regulated medical device or pharma environment. Consultant will perform validation duties in support of CFR Part 820, ISO 13485, CFR Part 11, etc. validation projects. Consultant reports into the SQA department and should have experience with Agile and waterfall SDLC methodologies and validation of SAAS systems. Systems to validate include:
- Clinical Software
- Technical spreadsheets
- SFDC also coming up
- Ability to work with non-QA staff to author requirements and other documents that meet good documentation practice
- Knowledge and application of GxP validation and risk management theories, principles and techniques used in medical device manufacturing.
- Experience authoring validation documents including requirements, protocols, trace matrices and reports
- Experience authoring and executing validation protocols/scripts
- Ability to function in a fast-paced startup environment
- able to work independently and as part of a multi-disciplinary team
- IQ,PQ,OQ skills
- good skill in CAPA.