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Role Overview
Reporting to the Senior Process & Technology Engineer, the Process & Technology Engineer is primarily responsible for supporting day-to-day production within the Biotools manufacturing areas and effectively implementing change management projects.
Responsibilities
1. Lead Process/Product Validations: Conduct validations in conjunction with Quality, Validation, and Operations teams. Prepare protocols, develop and execute plans, and compile reports.
2. Technical Support: Provide technical support for processing issues or changes in manufacturing processes. Lead troubleshooting using Root Cause Analysis and implement corrective actions.
3. Investigations: Investigate process, product, and quality issues to develop long-term solutions, liaising with external personnel and customers as needed.
4. Documentation: Maintain and develop manufacturing process documentation and procedures. Track all process changes and modifications.
5. Compliance: Ensure adherence to GMP and safety standards on equipment.
6. Risk Management: Lead risk mitigation initiatives like FMEA and risk assessments, developing risk-based change management approaches.
7. Feasibility Trials: Conduct process feasibility studies and DOE's to determine robust process parameters.
Desired Skills & Knowledge
* Knowledge of automated/semi-automated assembly equipment, injection molding, high-precision tooling, heat sealing, ultrasonic welding, leak testing, vision systems, OEE methodology, Minitab, Lean Six Sigma, AutoCAD.
Candidate Profile
* Bachelor’s degree in Mechanical, BioMedical, Process Engineering, or similar.
* At least 3 years of relevant experience, preferably in Medical Devices or regulated environments.
* Experience with product and process validations.
* Strong communication, process standardization, leadership, stakeholder management, and team skills.
* Ability to work in complex matrix organizations and demonstrate responsiveness to internal customers.
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