CSV Specialist (Cybersecurity project)

For Computer System Validation and Software services in the Manufacturing area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Life Science or Engineering and previous exposure in Computer System Validation activities within the regulated industry.
• 1-2 years of experience in validations and CSV.
• Support: Some activities might be conducted remotely, not more than 2 days/week.
• Bilingual, Spanish, and English.
• Shift: Administrative & according to business needs 
• Experience in:
  • Computer System Validation life cycle. 
  • Implementation of a Software revision on an existing application. 
  • GMP environment. 
  • Protocol execution and final report generation

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 functional verification for system migrated from old to new virtual servers. Update validation deliverables per new server IQ/OQ information.
• Test functionality is the same as it was in the old server.
• Update CyberSecurity procedure to reference new tools for managing service accounts for mfg/lab systems.
• Support deploying PRA (Probabilistic Risk Assesment) to remove non-compliant remote access tools to access the OT equipment and systems.
• Prepare all the required agile documentation once the new server is implemented. To migrate the system one by one and conduct functional verification via Agile documentation process.
• CSV lifecycle documentation development/revision: URS, VP, data integrity revision, test protocol development.
• Protocol execution and final report generation.
• Performs computerized systems validation for manufacturing facility’s cGMP IM systems, manufacturing automated process control systems and equipment.
• Responsible for the design, development and execution of software, computer validation protocols and computer validation plans, for the manufacturing operations.
• Develops Software/Computer Validation Protocols according policies on computerized systems validation. 
• Generates Final/Validation Report in accordance with actual FDA certification concepts.

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?