Validation Engineer I

1d1 day ago

Cook Medical

Bloomington, US · Full-time · $65,000 – $80,000

About this role

The Validation Engineer provides technical support for day-to-day production, engineering, and quality activities at Cook Polymer Technology. This role requires project management, team management, and leadership skills to coordinate efforts in maintaining the validated state of processes. The engineer helps support quality improvement, manufacturing changes, and process development.

The engineer develops validation and revalidation protocols, executes them, and summarizes activities. Execution involves interacting with processing systems, software systems, teams, and performing data analysis. Characterization of processes and their outputs and written preparation of validation reports are also key responsibilities.

This position supports production, engineering, development, quality teams, and management through validation and revalidation projects. The engineer reviews Process Failure Mode and Effects Analysis, updates Product Specification sheets, performs database queries, and participates in CAPA activities. Collaboration with multiple departments ensures compliance with regulatory and company standards.

As an early career opportunity, this role offers hands-on experience in medical device process development and validation. The engineer develops project management and leadership skills while contributing to quality improvement efforts. This position provides a foundation for advancing within the pharmaceutical and medical device industry.

Requirements

Bachelor’s Degree in Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, or a related field (or equivalent experience).
Minimum 1-3 years of experience in medical device process development or process validation.
Experience recording and analyzing data and clearly expressing conclusions and recommendations in writing.
Knowledge of validation protocols and regulatory standards (e.g., FDA QSR, ISO 13485).
Proficiency with data analysis tools and software (e.g., Minitab, Excel).
Ability to manage multiple projects and collaborate with cross-functional teams.
Familiarity with Process Failure Mode and Effects Analysis (PFMEA) and CAPA processes.

Responsibilities

Develop validation and revalidation protocols, execute them, and summarize activities.
Interact with processing systems, software systems, and cross-functional teams while performing data analysis.
Support production, engineering, development, quality, and management teams through validation and revalidation projects.
Characterize processes and their outputs/acceptance criteria.
Prepare written validation reports that meet regulatory and company standards.
Conduct verification testing and manage project activities.
Review Process Failure Mode and Effects Analysis, update Product Specification sheets, perform database queries, and participate in CAPA activities.