Validation Specialist

3 weeks ago


Plainfield, New Jersey, United States United Pharma Technologies Inc Full time
Job Summary:

As a Validation Specialist at United Pharma Technologies Inc, you will be responsible for managing specification, qualification, and validation requirements. This includes writing and executing engineering change orders related to Corrective and Preventive Actions (CAPAs), changes in Critical to Quality (CTQs), release of aging reports, and updates to design history files. You will also conduct Risk-based verification for GxP (GMP, GCP, and GLP) systems and laboratory equipment. Additionally, you will create and update Failure Mode and Effect Analysis (DFMEA) for new implants and instruments. Your skills in Auto Cad, Matlab, Kaizen, Minitab, Tally, Catia, Python, and Ansys will be utilized to design, develop, and oversee validation components and work on inspection plans and Inspection Feature Assessment.

Key Responsibilities:
Manage specification, qualification, and validation requirements
Write and execute engineering change orders related to CAPAs, CTQs, and design history files
Conduct Risk-based verification for GxP systems and laboratory equipment
Create and update DFMEA for new implants and instruments
Design, develop, and oversee validation components and work on inspection plans and Inspection Feature Assessment

Requirements:
Bachelor's degree in Mechanical Engineering, Industrial Engineering, Biotechnology Engineering, Science, Technology, or Engineering (any) with 5 years of experience in a related occupation is required. Skills in Auto Cad, Matlab, Kaizen, Minitab, Tally, Catia, Python, and Ansys are essential for this role.

Work Location:
South Plainfield, NJ and various unanticipated locations throughout the U.S. Send Resume to HR Dept., United Pharma Technologies, Inc., 908 Oak Tree Avenue, Suite A, South Plainfield, NJ 07080.

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