Added - 09 / 03 / 25 Validation Engineer - Process Development Engineering Dorado, Puerto Rico

Added - 09 / 03 / 25 Validation Engineer - Process Development Engineering Dorado, Puerto Rico | Contract

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Process Development Technician Dorado, Puerto Rico; Process Development Engineer Dorado, Puerto Rico; Process Development Validation Engineer Dorado, PR; Manufacturing Engineer I Juncos, PR

Pharma-Bio Serv , a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for over 30 years. Since our inception, our services have resulted in project experience level and personnel resource base ranking among the highest worldwide. Currently, one of our clients in the North Region is looking to hire a Validation Engineer - Process Development

Requirements

• BS Engineering with at least 3 years of medical devices or pharma experience.
• Support process and / or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products.
• Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities.
• Work with the Process Development team to efficiently qualify new processes; assist on statistical sampling plans, and other development procedures.
• Design and develop in-process and receiving quality systems for new processes and components.
• Generate equipment documentation, such as equipment entries, evaluations, PM and calibration procedures, as required.
• Define gages, tools and equipment for the test methods developed.
• Generate manufacturing instructions for new processes being developed.
• Work cross-functionally with other departments to accomplish PD tasks.

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