Validation Engineer

Cypress HCM · Sturtevant

FULL TIME

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

Company	Cypress HCM
Location	Sturtevant
Type	FULL TIME
Niche	Full-time

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