Job description
For Computer System Validation and Automation services in the Manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor’s Degree in Life Science or Engineering and three to five (3-5) years of exposure in Medical Device Industry.
- Bilingual English/Spanish, both written and verbal
- Shift: Administrative and according to business needs. Flexibility to work extended hours (can take work Saturday or Sunday)
- Experience in:
- Computer System Validation
- Rockwell Automation products
- Motion control and Machine Safety
- Troubleshooting, PLC, and Process Validation.
The Personality Part:
- If you feel a passion for transforming lives and innovating with new medical solutions, using global collaboration, high performance, diversity and winning spirit, then this is a job for you.
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Generate and execute equipment/software validation protocols (IQ/SQ, TMV, TQF, Process Characterization and Process Validation based on equipment capabilities.
- Generate and review Change Notice, Equipment Entries, PM generation and revisions, Evaluations, etc.
- Troubleshooting: Software (PLC-Vision), up to equipment/process related with guidance. Not just execution.
- Assure automated systems operations are maintained considering Plant policies, procedures and FDA regulations under cGMP’s and other regulations applicable.
- Install, configure, troubleshoot, and maintain automated systems in Automation Disaster Recovery.
- Test automated system to determine criticality of component loss, prioritize importance of components and write recommendations for recovering losses and using backup/restore applicable procedures.
- Assure reported problems are solved by implementing corrective actions.
BEING A FITS PIECE COMES WITH PERKS:
- One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you’ll be amazed). However, that’s not all we have to offer. Talk with us to find out!
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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