CSV Specialist

RCM Technologies • United States, United States • 3w ago

Full Time Contract Role: CSV Specialist Compensation: Up to $40/Hour Location: Puerto Rico, 100% Remote Length of Contract: 1 Year Position Description: The CSV Consultant is responsible for authoring, executing, and documenting computer system validation activities in compliance with applicable regulatory requirements. This role supports validated systems across the biotech organization and works closely with Quality, IT, vendors, and business stakeholders to ensure systems are fit for intended use Responsibilities:

Author, review, and execute computer system validation deliverables, including validation plans, risk assessments, test scripts (IQ/OQ/PQ or equivalent), and validation summary reports.

Ensure validation activities comply with regulatory and quality requirements (e.g., GxP, FDA, EMA, 21 CFR Part 11, Annex 11).

Collaborate with cross-functional teams including Quality Assurance, IT, Operations, and system owners.

Support validation of software systems such as LIMS, ELN, QMS, MES, ERP, and other regulated applications.

Participate in vendor assessments, system implementation activities, and change management processes.

Execute testing activities, document deviations, and support resolution and remediation efforts.

Maintain validation documentation in accordance with internal SOPs and quality standards.

Provide input to validation strategies and contribute to continuous improvement of CSV processes.

Qualifications:

5 years of hands-on experience in Computer System Validation within biotechnology, pharmaceutical, or life sciences environments.

Proven experience authoring and executing validation plans, test scripts, and validation summary reports.

Strong working knowledge of GxP regulations and data integrity principles.

Experience validating commercial off-the-shelf (COTS) and/or custom software systems.

Education & Certifications:

Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Information Technology) preferred.

Equal Opportunity Employer: 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.

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