Job description
Process Development Engineer/ Validation Engineer
A Medical Device client in Denver,Colorado is currently looking for Process Development Engineer to work on a 12-24 months contract with the possibility of extension/Direct hire. The selected person will be working an 8 am-4 pm Monday to Friday work schedule.
- Process Engineer (Onsite)
- Our client is a globally distinguished medical device manufacturer whose mission is to develop and commercialize lifesaving medical technologies for patients around the world.
- This project will require a team of Process Development Engineers (3) to support an ongoing development project.
- This project will give our consultants an opportunity to play a key role in ensuring our client is able to meet production and manufacturing timelines.
- Provide specification, start-up, and commissioning support for manufacturing equipment, facilities areas, and process utility systems.
- Prepare and review engineering/technical documents such as protocols, reports, manufacturing documentation, and vendor-provided documents and drawings.
- Ensure process and equipment designs are compliant with all Company/FDA Standards
- Planning of required validation activities, including both scoping and timeline development
- Generation and closing of Validation and Qualification Documents
- BS in Engineering
- 4+ years of medical device manufacturing experience
- Strong experience with equipment and process validation
- Experience with commissioning and qualification
- Experience writing and executing validation protocols