Validation Engineer

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.

Job Description

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.

Activities include:

• Creation and approval of IOQ documents from approved templates
• IOQ Execution, as applicable, identified per VMP.
• Completion and approval of final reports.

Qualifications

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.