Job Description Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing or new products.
Integrates equipment and material capabilities to meet process module target specifications and technology target specifications.
Reviews product development requirements for compatibility with processing methods to determine costs and schedules.
Interacts with product design and development personnel to ensure that processes and designs are compatible.
May develop and conduct statistical analysis or recommend additions to document work.
Leads 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.
Supports equipment installation and assessment of inputs, outputs and alignment to requirements.
Ensures processes and procedures are in compliance with regulations.
Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems.
Other duties may be assigned.
Resources are needed to work in new products and capacity increase projects. Main tasks will be to work with all documents of the validation lifecycle including development, execution and closure of documents/reports. Person needs to be able to work with root cause analysis and troubleshoot process, product and equipment as needed.
Requirements 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. Preferred Qualifications: Troubleshooting skills Validation lifecycle Root cause analysis Must be fully bilingual Requirements Investigation and root cause analysis skills.