About this opportunity
Cypress HCM lists this Validation Engineer opportunity in sturtevant, Wisconsin. Review the employer’s description below for duties, qualifications and application requirements.
Job description
We are looking for a contract to hire Validation Engineer to join our medical device manufacturing client in Southeastern Wisconsin! This position is responsible for writing, implementing, analyzing results and summarizing process validation activities in the areas of equipment installation, change management, and continuous lifecycle improvement. This individual will work through a validation backlog following the Quality System elements for process Validation including CAPAs and deviations. This position will work closely with members of the Quality Assurance, Manufacturing, and Engineering teams to develop process validation studies and projects to enhance the manufacturing processes to compliantly achieve organizational goals.
Duties Of Role
Provide technical input to validation activities
Represent process validation during equipment installations
Support process validation Quality Systems
Identify opportunities for personal and professional development, continuous improvements, and help deploy best practices
Participate in regulatory agency inspections for Process Validation
Serve as one of the main points of contact in communication to customers whose equipment and processes are being validated
Responsible for updating site Project Management and aiding in schedule and cost forecasting of validation activities
Must Haves:
3 or more years relevant experience in quality/validation
Experience authoring and completing validation studies.
Understanding of cGMP requirements for validation documentation.
Demonstrated ability to collaborate with multiple functions to implement validation activities and incorporate validation results into routine operational practices
Experience authoring and building process validation studies for commercial GMP manufacturing processes
Experience troubleshooting/problem-solving and risk assessment/mitigation
Working knowledge of the science and technology for the major unit operations associated with manufacturing operation is considered a plus.
Must be able to read, write and speak English
Hourly Rate of $40-50 while on contract
Worksite address
sturtevant, WI, 53177, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.