Responsible for supporting product development from concept through sustained manufacturing of FDA regulated products. Completion of process development, equipment acquisition and leadership of supporting development partners. Experience with manufacturing processes, quality/cost savings initiatives and implementation of engineering principles while assuring compliance with cGMP, quality and safety standards.
Essential Duties and Responsibilities
- Process development, equipment specification, acquisition and implementation.
- Evaluation of machine logic and controls to troubleshoot equipment and identify process improvement opportunities.
- Integration of controls hardware and software into new and existing manufacturing equipment.
- Design of experiments, validation, completion of testing and analysis of data.
- Suggests and supports new methods or materials for continual improvement of quality and efficiency.
- Analyzes current equipment for process suitability and provides detailed plans for improvement
- Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures and other technical documents to ensure compliant, efficient and safe procedures
- Works with other engineers and technicians in developing solutions and improvements in materials, equipment and process as necessary
- Actively participates in teams as necessary to ensure continual improvement, safety and compliance
- Lead cross functional project teams and coordinate activities.
Measures of Performance:
- Appropriate process and equipment definition.
- Quality of communication and documentation
- Time management and project metrics.
- Implementation of core engineering principles.
Education and/or Experience
BS in engineering or equivalent combination of education and experience.
engineering experience in a manufacturing environment
Experience working in a GMP, FDA, ISO and USDA regulated environment preferred