Title: Validation Engineer
Summary: An innovative leader in diagnostics is looking to bring on a talented validation engineer at this time! Working on a variety of diagnostic products, including at-home Covid-19 tests, insulin kits, biomarker assays and immunoassay plates. These diagnostic products are used across a wide therapeutic scope including cardiovascular, immunology, and oncology & cancer. My client is seeking someone that will be able to provide support for validation programs of equipment, instrumentation and process validation studies. If this sounds like something you can see yourself becoming a part of, I highly recommend applying!
The Validation Engineer will be responsible for:
- Writing validation protocols and reports.
- Performing validation activities including thermal studies, cleaning, process, methods, equipment and utilities validation.
- Preparing and reviewing completed and executed validation packages.
- Writing and reviewing validation plans, validation polices and procedures.
- Supporting implementation of validated system change requests and resolution of process deviations.
The Validation Engineer should have the following qualifications:
- Bachelor's degree in a scientific, engineering or technical discipline. Master's degree preferred.
- At least 5 years of relevant industry experience (medical device, in-vitro diagnostics, etc.)
- Experience with GMP and ISO9001:2000 validation standards.
- Worked with a variety of laboratory equipment, manufacturing processes, facilities and utilities equipment.
If you are interested in the Validation Engineer role, then please don't wait to apply!