Computer System Validation - Aibonito, Puerto Rico - RCM Technologies, Inc.

Descripción

Job Title: Computer System Validation.
Job Function: Perform computer system validation.
Job Type: Eight months minimum full-time contract.
Location: Aibonito, PR (On-Site).

Scope of Job
RCM is looking for a specialist to perform computer system validation (CSV) for Veeam & VMware applications for our pharmaceutical company client.

Primary Responsibilities

Perform computer system validation (CSV) activities following cGMP standard procedures.

Develop, approve, and execute CSV lifecycle documents such as: User Requirement Specifications Risk Management Report Validation Plan Functional Specifications Configuration Specifications Develop and Completion of OQ/PQ Protocols Development of Traceability Matrix Update the Standard Operating Procedures

Revise backup and disaster recovery SOPs, as applicable.

Complete training forms, as required.

Develop change control records, oversight and drives the change control from initiation through closure (including system release for use), assign impact assessors, obtain endorsements, etc.

Qualifications:

Experience must be within a pharmaceutical environment working in the developing and executing CSV protocols and developing and managing Change Control Records.

Knowledge of Veeam and VMware applications is a plus.

Capable of reading and interpreting drawings and design specifications and any other technical document.

Capable of understanding and using 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 are required.

Able to interact effectively with people to establish and maintain excellent working relationships 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.

Effective written and oral communication skills.

Customer service oriented and self-starter.

Ability to exercise good judgment.

Education & Certifications

Bachelor's degree in engineering, computer science, or related discipline, combined with four () years of CSV and Change Control Management working experience.

Equal Opportunity Statement
RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.