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Process Engineer
hace 4 semanas
As a Process Engineer I, you will play a key role in recommending and implementing equipment and process modifications to meet quality standards and improve production efficiencies. You will integrate equipment and material capabilities to meet process module target specifications and technology target specifications. Your responsibilities will include reviewing product development requirements for compatibility with processing methods to determine costs and schedules. You will interact with product design and development personnel to ensure that processes and designs are compatible. Additionally, you may develop and conduct statistical analysis or recommend additions to document work. You will lead the innovation, development, and/or optimization of new manufacturing concepts, processes, and procedures for transfer to manufacturing operations. You will develop, execute, and close protocols required as part of the validation lifecycle. You will support equipment installation and assessment of inputs, outputs, and alignment to requirements. You will ensure processes and procedures are in compliance with regulations. You will develop manufacturing processes that are applicable to statistical process control and may develop those techniques, including the measurement systems.
Key Responsibilities- Recommend and implement equipment and process modifications to meet quality standards and improve production efficiencies
- Integrate equipment and material capabilities to meet process module target specifications and technology target specifications
- Review product development requirements for compatibility with processing methods to determine costs and schedules
- Interact with product design and development personnel to ensure that processes and designs are compatible
- Develop and conduct statistical analysis or recommend additions to document work
- Lead the innovation, development, and/or optimization of new manufacturing concepts, processes, and procedures for transfer to manufacturing operations
- Develop, execute, and close protocols required as part of the validation lifecycle
- Support equipment installation and assessment of inputs, outputs, and alignment to requirements
- Ensure processes and procedures are in compliance with regulations
- Develop manufacturing processes that are applicable to statistical process control and may develop those techniques, including the measurement systems
- Minimum 2 years of experience in Validation Lifecycle in the regulated industry
- Process Validation and Computer Software Validation knowledge
- Experience in Equipment Validation
- Bachelor Degree in Engineering Completed
- Available to work 100% onsite in Ponce
- Troubleshooting skills
- Validation lifecycle
- Root cause analysis
- Must be fully bilingual