Job Title: Validation Engineer
Location: Mount Prospect, IL
Contract Length: 3-6 Months
Our client is a full service consulting firm who have helped pharmaceutical and medical device manufacturers bring products to market, providing engineering validation services and FDA regulatory affairs service.
We are seeking a creative, collaborative, and hands-on worker to provide quality support in a large manufacturing environment. As a company, they value personal accountability, corporate transparency, and professional development – a positive customer experience is as important as a positive employee experience.
The client, a pharmaceutical manufacturer is seeking Validation support for their facility build-out. This is a hybrid position, with time on-site as necessary to perform support of Validation and Qualification activities and creation and approval of deliverables. All assignments will be given and managed by the Compliance Team Lead.
- Creation and approval of IOQ documents from approved templates
- IOQ Execution, as applicable, identified per VMP.
- Completion and approval of final reports.
The ideal candidate will have the following skills and experience:
- 5-10 years' experience in project management, oversight, scheduling, and coordination for validation and/or capital projects
- Hands-on validation experience with utilities, process equipment and facilities equipment and systems
- Generation, execution, and reporting on IQ/OQ/PQ protocols
- Working knowledge of quality management systems, including 21 CFR 210, 211, 820.
- Ability to communicate (in oral and written forms) in a concise, clear and accurate manner.
- Proven ability to work constructively with a broad range of people, backgrounds, and functions.
- Proficient with basic word processing and spreadsheet software, as well conferencing applications.