CSV Specialist

Weil Group • Manati, PR

1d

About The Position

Perform Computerized System Validation (CSV) activities following site CSV Standard Procedure. Develop change control records, as required, following 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.

Requirements

• Bachelor’s Degree in Engineering or Computer Science
• 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.
• Read and interpret drawings and design specifications and any other technical document.
• 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
• 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.
• Able to plan and prioritize multiple activities simultaneously.
• Customer service oriented and self-starter.

Responsibilities

• Perform Computerized System Validation (CSV) activities following site CSV Standard Procedure.
• Develop change control records, as required, following 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees