Validation Engineer (Direct hire, No C2C)
In order to be considered for this position, you must be authorized to work in the United States without requiring visa sponsorship.
This exciting career opportunity is with a rapidly expanding consumer products company that specializes in the production of creams, ointments, drugs, and related products. The facility is located in the scenic area of North Central IL, near the Illinois River and popular hiking destinations like Starved Rock. It is conveniently situated just a short drive away from O'Hare International Airport.
Primary responsibilities of this role include assisting in the validation of cGMP equipment, facilities, and processes. This involves validating laboratory systems, production equipment, manufacturing processes, and utilities. As a Quality Assurance Engineer, you will also have the opportunity to mentor a junior Validation Engineer.
- Develop, review, and execute validation protocols.
- Conduct studies to improve processes and facilitate the launch of new products.
- Maintain equipment logbooks and documentation related to usage, cleaning, and sterilization.
- Provide validation support to various internal departments, including Maintenance, Quality, Regulatory Affairs, R&D, Manufacturing, and other users of validation services.
- Ensure compliance with cGMP requirements and ISPE standards during validation activities.
- Promote and maintain best practices to establish a consistently controlled environment.
- Pay strong attention to detail, ensuring tasks are completed accurately and efficiently.
- Interpret and apply Quality and Best Practice Qualification and Validation standards for implementation and review.
Perform IQ/OQ/PQ activities for facilities and utilities
· Complete Change Controls for Manufacturing Equipment, Processes, and Facility/Utility Systems
· Perform Periodic Reviews and re-validate manufacturing processes, equipment, as well as Facility and Utility Systems.
• 3-5 years of experience in validation work within pharma, medical devices, or related fields
• Proficiency in developing and executing equipment IQ/OQ/PQ protocols
• Preferred experience in Refrigerator/Freezer/Incubator Temperature Mapping
• Facility/Utility validations (HVAC, RODI/Purified Water/Compressed Gases)
• Understanding of Change Control Documentation
• Ability to create engineering change control documents and testing protocols for change controls