CSV Specialist Support

To support the Information Technology Department. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering or Computer Science combined with three (3) years of CSV and Change Control Management working experience. Experience must be within a pharmaceutical environment working in the developing of CSV assessments and testing protocols and developing and managing Change Control Records.
• Experience in:
  
  • Drawings and design specifications and any other technical document.
  • Capable to understand and use computers and software packages.
  • Knowledge of cGMP’s, local/federal regulatory requirements and documentation procedures pertaining to pharmaceutical manufacturing plant.
  • Bilingual English/Spanish, both written and verbal are required.
  • 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.

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 BMS CSV Standard Procedure.
• Develop change control records, as required, following BMS Electronic Change Control (e-CC) Procedure for the Manati 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.

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?