Due to tremendous growth, Indeio is looking for a Principal Validation Engineer to help continuously develop and enhance our portfolio of industry leading talent.
We are a spirited, high-growth company focused on the success of our clients and our colleagues. We put a new spin on consulting that allows our team to work at or with some of the world's largest and well-known medical device and pharmaceutical companies.
- Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation.
- Must be able to read and understand engineering P&ID's and turnover documentation.
- Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.
- Contribute to risk management activities including PFMEA generation.
- Complete test method validation, gauge r&r studies and other qualifications or studies to support product testing.
- Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
- Change control, non-conformance and CAPA support.
- Participate in FDA inspections, ISO certifications, surveillance audits and customer audits.
- 2-5 years of experience in a Validation or Quality Assurance role for a medical device environment.
- Bachelors Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry).
- Experience with qualifying medical device manufacturing equipment.
- Candidate must possess sufficient knowledge and experience to serve as a subject matter expert within one area of validation.
- Results oriented with a strong focus on quality principles.
- Experience conducting validation studies and managing projects independently.