What are the responsibilities and job description for the Process Development Engineer position at The Fountain Group?
Job Duties:
- Author and execute Process Validations including Test Method Validation (TMV), Inspection Method Validation (IMV), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ).
- Responsible for process development, equipment specification, acquisition and implementation.
- Understands engineering principles theories, concepts, practices and techniques.
- Analyzes and solves problems from basic engineering principles.
- Completes design of experiments, validation, completion of testing and analysis of data for continuous improvement activities. Presents data to equipment teams.
- 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.
- Participates in teams as necessary to ensure continual improvement, safety and compliance.
- Provides training and process expertise for product processing in specific areas such as process development, tooling development and validation.
- Interacts cross functionally and with internal and external customers.
Qualifications:
- Bachelor’s or Master’s degree in Technical Discipline and 5 years’ experience with Process Development and Validation / Qualification (TMV, IQ/OQ/PQ).
- Previous experience In the medical device industry.
