CSV - Validation Lab Specialist

For Computer System Validation services in the Laboratory area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Life Sciences or Engineering combined with three (3) years of CSV and Change Control Management working experience. 
• Bilingual English/Spanish, both written and verbal are required.
• Shift: Administrative and according to business needs. 
• Able to interact effectively with people to establish and maintain excellent working relationship with internal and external customers at all organizational levels and disciplines in such a way to facilitate the work.
• Experience in:
  • Pharmaceutical environment working in the developing of CSV assessments and testing protocols and developing and managing Change Control Records.
  • Drawings and design specifications and any other technical document.
  • Capable to understand and use computers and software packages
  • cGMP’s, local/federal regulatory requirements and documentation procedures pertaining to pharmaceutical manufacturing plant.

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 following site CSV Standard Procedure.
• Develop change control records, as required, following site Electronic Change Control (e-CC) Procedure for the Site.
• Communicate to IT and CSV leaders the tasks progress and roadblocks, or any requirements not met by the project.
• Collaborate with other department members to review/update documentation related to the projects assigned.
• Develop the testing protocols in the Application Lifecycle Management (ALM) System and/or any other required documentation procedures (such as DCA System for Document Control and Archiving).
• Coordinate meetings with technical or other multidisciplinary teams to develop and revise required documents.

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?