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 Medical Device sector is looking to hire a Process Development Engineer in Dorado, Puerto Rico.

Requirements:

• Bachelor’s degree, with 5 - 7+ years in manufacturing engineering or quality engineering within an FDA‐regulated environment (medical devices, pharma, diagnostics, biotech).
• Electrical and mechanical engineering background applied to automated manufacturing systems.
• Experience with automation/controls, tooling, fixtures, test method development, and equipment qualification.
• Proficiency in DOE, FMEA, CAPA, and root‐cause investigation.
• Experience supporting new product introductions and process scale‐up.
• Strong working knowledge of 21 CFR Part 820, GMP, and ISO 13485.
• Fully Bilingual Spanish & English