CSV Specialist

Manati, Puerto Rico · Biotech/Pharmaceutical

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

Minimum Requirements/Qualifications

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.
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.