Quality Assurance Engineer (Direct hire, No C2C)
To be considered for employment you must have legal authorization to work in the United States for any employer and you will not require employment visa sponsorship at any point.
This job opportunity is with a growing company that manufactures creams, ointments, drugs, and related products. They are a contract manufacturer providing turn-key solutions. The plant is located in La Salle, IL near the beautiful Illinois River, Starved Rock, and other hiking destinations. It is conveniently situated just an hour and 45 minutes away from O'Hare International Airport.
- Assist in the validation of cGMP equipment, facilities, and processes, including laboratory systems, production equipment, manufacturing processes, and utilities.
- Provide support to a junior Validation Engineer and act as a mentor.
Essential Duties and Responsibilities:
- Write, review, and execute protocols.
- Write, review, and execute studies for process improvement and new product launch.
- Maintain equipment logbooks and other forms to document use, proper cleaning, and sterilization.
- Provide validation support to various internal customers, such as Maintenance, Quality, Regulatory Affairs, R&D, Manufacturing, and others.
- Ensure that all validations are performed in compliance with cGMP requirements and standards.
- Establish and maintain good practices to ensure an environment consistently within a state of control.
- Pay strong attention to detail and complete tasks with accuracy and efficiency.
- Interpret and apply Quality and Best Practice Qualification and Validation standards.
Additional Activities Include:
- IQ/OQ/PQ activities for facilities/utilities
- Completing Change Controls for Manufacturing Equipment, Processes, Facility/Utility Systems
- Completing Periodic Reviews and re-validation of manufacturing processes and equipment, as well as Facility and Utility Systems.
- 3-5 years of experience with validation work in pharma, medical devices, or closely related fields
- Experience with equipment IQ/OQ/PQ protocol development and execution
- Preferred experience in Refrigerator/Freezer/Incubator Temperature Mapping
- Facility/Utility validations (HVAC, RODI/Purified Water/Compressed Gases)
- Experience with Change Control Documentation
- Experience with creating engineering change control documents and testing protocols associated with change controls