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 seven (7) years of exposure in the Pharmaceutical or Medical Devices industry. Bilingual (Spanish and English) Shift: Administrative & according to business needs Experience in: Validation protocolos Remediation activities Documentation 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) Perform assessments and review of all manufacturing and validation documentation associated to product families established by EU MDR and Design History File (DHF) remediation program.
Provide data to support the gap assessments reports and identify remedial action items based on the outcome of gap assessments.
Complete assigned remediation activities to ensure that manufacturing processes and operations are in compliance with requirements of EU MDR.
Generate and execute validation protocols, including the coordination of all activities required for protocol completion.
Interact and coordinate activities with other departments, external vendors, and customers, as required.
Update documentation associated with manufacturing processes which can include drawings, specifications, bill of materials, production router/instructions, procedures, labeling, and process flow charts, among others.
Provide training in the updated manufacturing documentation as applicable.
Analyze manufacturing process information/data, and develop, where necessary, technical justification, rationale, and/or other information as required by the company to mitigate risk to an acceptable level with adequate documentation.
Report project status and progress periodically to site management.
Perform other related duties, as required.
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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