Process Development Engineer
Pharma-Bio Serv
- Dorado, PR
- Permanent
- Full-time
- Bachelor's degree in Engineering with a minimum of 4 years of relevant experience manufacturing engineering or quality engineering within an FDA-regulated environment (medical devices, pharma, diagnostics, biotech).
- Support manufacturing basic daily activities and/or continuous improvement projects such as; equipment troubleshooting, root cause analysis and non-conforming product evaluation.
- Completes technical activities leading to new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company. Prepares reports, publishes, and makes presentations to communicate findings.
- Analyzes and solves problems from basic engineering principles, theories and concepts through to a wide range of problems which require novel and new innovative approaches.
- Cultivates internal and external network of resources to complete tasks. Participate in project teams to complete goals and objectives for the projects.
- Interacts cross functionally and with internal and external customers.
- Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products.
- Work with the Process Development team to efficiently qualify new processes; assist with statistical sampling plans, and other development procedures.
- Bilingual (Spanish & English)
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