|Posted On||Oct 07, 2021|
We are currently looking for a Validation Engineer for a local manufacturing facility.
- BS in Engineering/Biochemistry required
- Proven understanding of compounding sterile pharmaceuticals in an FDA 503B environment
- Previous interaction with audits and development of audit responses
- Aseptic processing
- FDA/GMP/and ISO standards
The Validation Engineer will be able to develop GxP system lifecycle documentation that includes validation plans, user requirement specs, Functional requirement specs, testing protocols, user acceptance testing, traceability matrices, final reports, SOP’s, change control docs, and risk assessment reports as required. You will assist in developing company policy regarding validation processes, as well as lead validation activities on medium to large projects. You will also work with other areas on their validations for processes and procedures.