CSV Specialist

Flexible & Integrated Technical Services • Manati, PR

9d

About The Position

For Validation services for the Manufacturing area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor’s Degree and five (5) years of experience in Computer System Validations within the Pharmaceutical Industry. Bilingual: Spanish and English. Soft Skills: Collaborative attitude and Strong communication skills. Shift: Administrative and according to business needs. Experience in: Computerized System Validation, and Data Integrity. 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 Be The Piece? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Provide computerized system validation support related initiatives in Manatí site. This support includes the development of validation documents, routing, execution, and any other CSV Lifecycle document. Provide computerized system validation support during the implementation of project initiatives in Manatí site. Development of validation documents, routing, execution, and any other CSV Lifecycle document development required as part of the implementation. Support CSV IT Compliance activities. Provide support to the System Audit Trails. 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. 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?

Requirements

• Bachelor’s Degree and five (5) years of experience in Computer System Validations within the Pharmaceutical Industry.
• Bilingual: Spanish and English.
• Collaborative attitude and Strong communication skills.
• Experience in: Computerized System Validation, and Data Integrity.

Responsibilities

• Provide computerized system validation support related initiatives in Manatí site.
• This support includes the development of validation documents, routing, execution, and any other CSV Lifecycle document.
• Provide computerized system validation support during the implementation of project initiatives in Manatí site.
• Development of validation documents, routing, execution, and any other CSV Lifecycle document development required as part of the implementation.
• Support CSV IT Compliance activities.
• Provide support to the System Audit Trails.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees