QC and CVS Specialist

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?