For Computer System Validation services in the Laboratory area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor's Degree in Engineering or Life Science, with at least three (3) years of experience in Computerized System Validation (CSV), particularly in laboratory environments.
Bilingual English/Spanish, both written and verbal are required.
Shift: Administrative and according to business needs.
Experience in:
The pharmaceutical environments, specifically developing CSV assessments, testing protocols, and managing Change Control Records for lab systems.
Reviewing and interpreting drawings, design specifications, and other technical documentation relevant to laboratory equipment and systems.
Proficient in using computers and various software packages for system validation and documentation.
GMPs, local and federal regulatory requirements, and documentation procedures applicable to pharmaceutical manufacturing and laboratory operations.
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 Computerized System Validation (CSV) activities in compliance with the site's CSV Standard Procedures, ensuring laboratory systems meet regulatory and operational requirements.
Create and manage change control records as needed to maintain compliance and document system updates.
Provide regular updates to IT and CSV leaders on task progress, potential roadblocks, and any unmet project requirements, ensuring transparency and proactive issue resolution.
Collaborate with cross-functional teams to review and update project-related documentation, supporting accurate and compliant records for lab systems.
Develop testing protocols and other required documentation and maintain control through the DCA System for Document Control and Archiving, ensuring consistency and traceability.
Coordinate meetings with technical and multidisciplinary teams to draft, review, and revise necessary documentation, fostering collaboration for lab system validation projects.
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?
PIKNJmoEzt