This career opportunity is with a growing consumer products company that manufacturers creams, ointments, drugs, and related. They are a turn-key solutions contract manufacturer. The plant is based in North Central IL on the beautiful Illinois River near Starved Rock and other great hiking destinations. Just an hour and 45 minutes drive to O'Hare International Airport.
Support validation of cGMP equipment, facilities, and processes. These duties will include but are not limited to validation of laboratory systems, production equipment, manufacturing processes and utilities. In this role you will also support a junior Validation Engineer and have the opportunity to 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.
- Maintains equipment logbooks and other forms to document use, proper cleaning and sterilization.
- Provide validation support to internal customers such as Maintenance, Quality, Regulatory Affairs, R&D, Manufacturing and other users of validation services.
- Assure that all validation are performed in compliance with cGMP requirements and ISPE standards.
- Establish and maintain good practices in association with processes and/or internal conditions leading to an environment consistently within a state of control.
- Strong attention to detail; Ability to complete tasks with accuracy and efficiency.
- Ability to interpret and relate Quality and Best Practice Qualification and Validation standards for implementation and review.
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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.
General Requirements:
◉ 3-5 years of experience with validation work in a pharma, medical devices, or closely related
◉ Experience with equipment IQ/OQ/PQ protocol development and execution
◉ Refrigerator/Freezer/Incubator Temperature Mapping Experience preferred
◉ 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