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?
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