Validation Engineer

Overview

Contract, 3 months | Automated Systems, Inc. | United States

Posted On 09/17/2024

Gurnee, IL - ONSITE

Duration: 3 months minimum

Pharma/Biotech/Clinical Research

State/Province:
Illinois

City:
Gurnee

ZIP: 60031

• Responsible for development, execution & analysis of validation projects to demonstrate facility cGMP compliance.
• Author and execute IQ/OQ/PQ Protocols for packaging equipment and operations.
• Author, change controls, SOPs, and work instructions.
• Provide technical assistance to change controls, CAPAs, 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.
• All validation work will be in support of oral solid dose pharmaceutical manufacturing of tablets, capsules, and powders.
• Expertise with the following equipment is desirable:
  Bottle Fillers, Blister Fillers, Labelers, Uhlmann Thermoformers.

• A Bachelor’s of science degree in Pharmacy, Engineering or Science is required.
• 2+ years of experience in life sciences engineering is required.
• 1+ years of experience in validation is required.
• 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.