Validation Engineer (Architecture and Engineering) at Automated Systems, Inc.

Validation Engineer

Location: Madison Area, WI - ONSITE

Contract: 6+ months with strong potential for extensions

Job Summary:

This position is responsible for development, execution, & analysis of validation projects to demonstrate facility, equipment, and process consistency and cGMP compliance for a sterile fill client. Responsibilities include the generation and execution of IQ/OQ/PQ protocols and summary reports. The selected will also collaborate with internal and external technical and management personnel to establish project priorities, goals, structure, and optimization of validation approaches. 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. 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, Cappers, Labelers, Bar coding, Uhlmann Thermoformers, Case packers

Job Description:

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

· 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, Experience and Skill Requirements

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

· 2+ years of experience in life sciences engineering is required.

· 2+ 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.