Validation Engineer – Pharmaceutical Manufacturing
Location: North Chicago, IL | Onsite
Job Type: Contract (6+ months, potential for extensions)

OVERVIEW:

Automated Systems, Inc. is seeking a skilled Validation Engineer to support a global pharmaceutical manufacturing client located in North Chicago, IL. In this role, you will lead validation initiatives for equipment, processes, and facilities to ensure compliance with cGMP standards. This is a hands-on, high-impact role for an experienced Validation Engineer looking to work on full-cycle validation projects in a regulated setting.

QUALIFICATIONS:

· Bachelor’s of science degree in Pharmacy, Engineering or Science is required.
· 3+ years of experience in validation and life sciences engineering 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 Process Validation requirements.
· 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.
Job Types: Full-time, Contract
Pay: $38.50 - $50.00 per hour
Expected hours: 40 per week

Benefits:

• Dental insurance
• Flexible spending account
• Health insurance
• Paid time off
• Referral program
• Vision insurance

Work Location: In perso

· 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.