Validation Specialist

ABOUT COMPLIANCE TEAM

Since 2003, our life science compliance consultants have helped pharmaceutical and medical device manufacturers bring lifesaving products to market. We provide engineering validation services and FDA regulatory affairs services to life science companies across the United States. We are seeking a creative, collaborative, and hands-on worker to provide quality support in a large manufacturing environment. We value personal accountability, corporate transparency, and professional development – a positive customer experience is as important as a positive employee experience. We thrive on hard work and fun!

Position Description

Our 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.

This position is expected to be of three-month duration.

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.

PHYSICAL REQUIREMENTS:

• Ability to walk down equipment in an industrial production setting - including walking on wet floors, stooping, swabbing under confined space permits, and walking distances to cover the extent of a large production facility.
• Ability also to sit for extended periods of time at a computer terminal.
• Drug test and pre-employment background check will be required to be eligible for hire.

Job Types: Contract, Temporary

Pay: $50.00 - $70.00 per hour

Benefits:

• Flexible schedule

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Mount Prospect, IL 60056: Reliably commute or planning to relocate before starting work (Required)

Experience:

• validation: 5 years (Required)

Work Location: Hybrid remote in Mount Prospect, IL 60056