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Cypress HCM · 8 hours ago

Validation Engineer

Sturtevant, WI

Contract

Onsite

Mid Level

3+ years exp

Cypress HCM is seeking a Validation Engineer responsible for writing, implementing, analyzing results and summarizing process validation activities. The role involves working closely with Quality Assurance, Manufacturing, and Engineering teams to enhance manufacturing processes and ensure compliance with organizational goals.

Human ResourcesInformation TechnologyStaffing Agency

Growth Opportunities

Responsibilities

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

Qualification

Process ValidationCGMP RequirementsValidation StudiesTroubleshootingEnglish Language

Required

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

Must be able to read, write and speak English