CSV Specialist
RCM Technologies View all jobs
- Manatí, PR
- Permanent
- Full-time
Location: 100% Onsite Manati, PR
Length of Contract: 6+ MonthsPosition DescriptionThe CSV Specialist is responsible for managing and executing all activities related to Computer System Validation (CSV) throughout the full system lifecycle. This role ensures that computerized and automated systems-including manufacturing equipment, lab instrumentation, and IT infrastructure-comply with our Client CSV Standard Procedures , FDA 21 CFR Part 11 , and GAMP 5 guidelines.Responsibilities
- Lifecycle Documentation: Author, review, and execute validation deliverables including Validation Plans, User Requirement Specifications (URS), Functional Requirements (FRS), Risk Assessments (FRA/DRA), IQ/OQ/PQ protocols, and Traceability Matrices (TM).
- System Compliance: Perform 21 CFR Part 11 and Data Integrity (ALCOA+) assessments for standalone and networked systems
- Process Support: Support the implementation of project initiatives at the Manati' site, specifically for Manufacturing (GxP) and Laboratory environments.
- Change Control: Develop and manage electronic change control records (e-CC) following client-specific site procedures.
- Audit Readiness: Serve as a Subject Matter Expert (SME) during internal audits and external regulatory inspections (FDA).
- Automation Integration: Collaborate with Automation and Engineering for systems involving PLCs, HMIs, Robotics, and LIMS/SAP interfaces.
- Experience: 5+ years of CSV experience within the Pharmaceutical or Biotechnology industry.
- Skills: Proficiency in GAMP 5, SDLC, and Data Integrity remediation.
- Bilingual: Fully bilingual (English and Spanish) with strong technical writing skills.
- BS in Computer Engineering, Computer Science, Biology, or a related technical field.
RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.Pay Transparency:
RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices.About RCM:
RCM is publicly traded on Nasdaq under the symbol RCMT. RCM is a business and technology solutions provider with world-class talent in key market segments. We help design, build, and enable the Industries of Tomorrow, Today. Operating at the intersection of resources, critical infrastructure, and modernization of industries, RCM is a provider of services in Life Sciences, Data & Solutions (IT), Healthcare, Engineering, Aerospace & Defense, and Process & Industrial.Disclaimer:
This job posting is intended to describe the general nature and the level of the work to be performed. 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.