Validation Engineer Process Development
For Process Development and Validation services in the manufacturing area.
WHAT MAKES YOU A FIT: .png)
The Technical Part:
- Bachelor Degree in Engineering and three (3) years of experience in the medical devices industry.
- Bilingual: English and Spanish
- Skills: Writing Skills
- Shift: Administrative, and according to business needs.
- Experience in:
- Process and/or equipment validation activities (IQ, OQ, PQ).
- Responsible for reviewing and developing process validation protocols and reports.
- Automation systems testing.
- Process Development and/or Manufacturing Process Engineering.
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 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 with 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.
- Assures that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
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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