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We are seeking a Process Engineer to support daily manufacturing operations for a leading medical device environment. The ideal candidate will bring strong technical expertise in process engineering, validations, investigations, and continuous improvement within regulated industries.
Key Responsibilities
- Support daily manufacturing and process operations.
- Lead and participate in process validations, including:
- Protocol development
- Execution
- Data analysis
- Final report generation and closure
- Conduct root cause investigations and implement corrective actions.
- Support Quality Notifications (QN) and CAPA investigations through closure.
- Troubleshoot manufacturing issues affecting product quality, yield, and efficiency.
- Collaborate with cross-functional teams including Quality, Manufacturing, Validation, and Engineering.
- Provide technical support for both manual and automated production systems.
Requirements
- Bachelor's Degree in Engineering (Mechanical, Chemical, Industrial, Biomedical, or related field).
- Strong experience in the Medical Device industry (required).
- Pharmaceutical industry experience (preferred).
- Demonstrated experience with validation activities (write, execute, analyze, and close protocols/reports).
- Experience performing root cause analysis and implementing solutions.
- Experience leading and supporting investigations, QN, and CAPA closures.
- Experience working with manual and automated manufacturing systems/production lines.
- Ability to work effectively in a fast-paced manufacturing environment.
- Bilingual (English and Spanish) required.
- Availability to work in Texas.
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