Validation Engineer

Flexible & Integrated Technical Services Ver todas las vacantes

Añasco, PR
Permanente
Tiempo completo

Hace 8 horas
Postúlese fácilmente

For Validation services in the Engineering area.WHAT MAKES YOU A FIT:The Technical Part:

Bachelor's Degree in Engineering and at least three (3) years of previous exposure to Validation or Quality Engineering activities within the Pharmaceutical or Medical Devices industry.
Bilingual, Spanish and English (good communication)
Shift: Administrative & according to business needs
Experience in:

Approving or reviewing change controls, validation plans, IQ/OQ/PQ protocols and Reports and SOPs changes.
Writing and reviewing IQ/OQ/PQ protocols and summary reports.
Utilities qualification and associated protocols/reports
cGMP, FDA regulations, and ISO 13485 requirements

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)

Review, approve, and manage change controls to assess technical impact, validation status, and regulatory risk.
Develop, review, and execute validation strategies and plans for equipment, processes, and utilities.
Author, review, and approve IQ/OQ/PQ protocols and summary reports.
Review/approve utilities protocols and qualification documentation (e.g., AHU, City Water, Electricity).
Review and Approve validation-related procedures, work instructions, and templates.
Support deviation investigations, and risk assessments related to validated systems and processes.
Collaborate with cross-functional teams to ensure validation deliverables are completed on 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?Powered by JazzHR

Flexible & Integrated Technical Services