Process Development Engineer
For Process Development services in the Process Engineering area.
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The Technical Part:
- Bachelor Degree in Engineering and at least five (5) years of experience within the medical devices or pharmaceutical industry.
- Bilingual: English and Spanish
- Soft Skills: Great attitude and strong desire to learn new skills.
- Shift: Administrative, and according to business needs.
- Experience in:
- 21 CFR Part 820, GMP, and ISO 13485 regulations.
- Electrical and mechanical engineering applied to automated manufacturing systems.
- automation/controls, tooling, fixtures, test method development, and equipment qualification.
- DOE, FMEA, CAPA, and root‑cause investigation.
- Supporting new product introductions and process scale‑up.
The Personality Part:
Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Support IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans.
- Design and develop in‑process and receiving inspection systems for new components and processes.
- Generate equipment documentation (evaluations, PM/calibration procedures) and manufacturing instructions.
- Manage process development projects from concept through implementation; collaborate with cross-functional teams.
- Apply DOE, PFMEA, and risk analysis to characterize, optimize, and improve manufacturing processes.
- Work with technologies such as laser welding, heat bonding, injection molding, vision systems, and automation (PLC/servo/pneumatics/sensors).
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the next piece?
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