Germer International
Equipment Validation Specialist
Germer International, Oregon, Wisconsin, United States, 53575
This is a full-time position. Are you detail-oriented with a passion for ensuring high quality standards in a pharmaceutical manufacturing environment? Then this position is for you The Validation Specialist is responsible for preparing and executing validation protocols for cGMP processes, production/laboratory equipment, cleaning procedures, and software in compliance with Q7. The Validation Specialist will assist with and write final reports for executed validation protocols. If you're interested in this position, apply here or reach out directly to Hannah Ferguson at hferguson Education and Requirements: Bachelor's Degree or above in Chemistry, Biological Sciences or Engineering (Chemical, Electrical, Mechanical, Reliability) or related discipline 2 years of related pharmaceutical CDMO experience Responsibilities: Provide technical assistance to other Validation staff and all other departments regarding validation issues. Write and/or revise department and company SOPs. Write and/or review validation and qualification protocols (including specification documents, impact assessments, Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Process Validations, and Cleaning Validations). Serve as Validation representative for cross functional projects. Complete qualification/validation protocols (including final reports). Participate in external audits (customer, FDA, etc.).