For Project Validation services in the Engineering & Manufacturing areas.
WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering or Science and at least five (5) years of exposure to sterilization activities within the Pharmaceutical or Medical Devices industry. Bilingual (Spanish and English) Shift: Administrative & according to business needs Experience in: Validation Life Cycle EU MDR or MDD remediation projects, compliance projects and process validation required.
Managing documents within electronic PLM system GMP & GDP regulations 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 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) Data Gathering – Participate in the discovery and compilation of required documentation to be evaluated.
Labeling / artworks changes implementation – Assess and update all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production router/instructions, procedures) to implement Labeling / artworks changes.
Perform tasks identified as part of the implementation plan including, but not limited to generation and execution of change control, technical reports / memos, First Article Inspections, and manufacturing documentation update through site change orders system (Agile).
The incumbent will be working with cross-functional areas on activities described above.
Responsible for the delivery of tasks to ensure conformance to the project plan schedule.
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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