Validation Engineer

Validation Engineer

Location: North Chicago, IL - Onsite

Contract: 9+ months duration with strong potential for extensions

Automated Systems, Inc. is seeking a Validation Engineer to join our team for one of our global pharmaceutical manufacturing clients based in North Chicago, IL. In this role, you will be responsible for development, execution, and analysis of validation projects to demonstrate facility, equipment, process consistency and cGMP compliance. 

Other duties include providing validation project management associated with new or modified facilities, acting as interface between various functional areas (internal and external) to assure successful integration and completion of validation activities in overall project schedules. 

Job Role Responsibilities: 

• Responsible for development, execution & analysis of validation projects to demonstrate facility cGMP compliance. 

• Responsible for the generation and execution of IQ/OQ/PQ protocols and summary reports.  

• Collaborate with internal and external technical and management personnel to establish project priorities, goals, structure, and optimization of validation approaches.

• Author and execute IQ/OQ/PQ Protocols packaging equipment and operations.

• Autor change controls, SOPs, and work instructions.

• Provide technical assistance to change controls/CAPA’s, and deviations.

• Design and execute process and cleaning validation studies meeting site and industry standards.

• Assist with product changeovers, troubleshooting investigations and continuous improvement initiatives.

• Collaborate with internal and external technical and management personnel to establish project priorities, goals, structure and optimization of validation approaches.

Education and Experience Requirements:

• A Bachelor of Science degree in Pharmacy, Engineering or Science is required. 

• 3+ years of experience in life sciences engineering is required.

• 3+ years of experience in validation is required.

• Expertise with the following equipment: bottle fillers, blister fillers, cappers, case packers, labelers, bar coding, and Uhlmann thermoforms. 

• Knowledge of cGMP Cleaning Validation and cGMP Process and Product Validation requirements and techniques desired.

• Experience working in FDA/cGMP compliant environment required.

• Strong collaboration, communication, and presentation skills required.

• Expert-level proficiency with Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.