Computer System Validation (CSV) Specialist -Software/IT Systems

RCM Technologies, Inc.; United States; Hybrid; USD 68,000 - 97,000; Full time

Job summary

RCM Technologies, Inc. is seeking a Senior Validation Associate focused on computer system validation (CSV) of GxP software systems. The role is remote with on-site travel to execute validation protocols and ensure compliance with 21 CFR Part 11, Annex 11, and GDP standards.

You will author CSV deliverables, perform risk assessments, and lead validation activities for GAMP category systems while maintaining data integrity and system security across validated software platforms.

Qualifications

• 10+ years in FDA-regulated industries with GMP, GAMP-5, 21 CFR Part 11, Annex 11.
• 8+ years in CSV document authoring, SOP revisions, and protocol execution.
• Ability to manage multiple concurrent validation or system implementation projects.
• Excellent written and verbal communication; strong cross-functional collaboration.
• Self-motivated, adaptable, customer-focused with leadership and problem-solving skills.

Responsibilities

• Lead and manage CSV projects, including scheduling vendor activities and authoring validation deliverables.
• Author validation deliverables such as requirements, risk assessments, traceability, validation plans and reports, IQ/OQ/PQ, and periodic reviews.
• Provide on-site support during validation execution and train staff on CSV as applicable.
• Conduct risk assessments and identify qualification/validation needs for new software systems.
• Investigate deviations and CAPAs and participate in GDP/compliance activities; ensure data integrity and access controls.

Skills

CSV leadership

GxP knowledge

21 CFR Part 11

Annex 11

Communication

Cross-functional

Education

BS degree in science/engineering/CS

Tools

GDP/ALCOA+

Job description

Title or Role: Senior Computer Systems Validation Associate

Compensation: Up to $60/hr., commensurate with experience

Location: Remote with on-site travel required when executing validation protocols

Length of Contract: Up to 1 year

Position Description:

Our client is a growing pharmaceutical company who seeks a Senior Validation Associate with strong Computer System Validation (CSV) experience. This role is 100% Computer System Validation of GxP software systems (e.g., LIMS, MES, QMS, ERP). It is NOT equipment, process, cleaning, or facilities validation, and NOT a QA oversight/approver role.

You will execute validation protocols yourself for GAMP 5 Category 3, 4 and 5 GxP systems, and qualify GAMP 5 Category 1 software tools. You will work remotely on validation documentation and travel on-site to execute protocols.

Responsibilities:

• Lead and manage computer system validation (CSV) projects, including scheduling vendor activities, authoring validation deliverables and protocols ensuring compliance with 21 CFR Part 11, Annex 11, GxP, and internal corporate policies.
• Authoring CSV deliverables such as Requirement Specifications, Risk Assessments, Traceability Matrix, Validation Plans, Validation Summary Reports, Installation Qualifications, System Acceptance Testing, and User Acceptance Testing, Periodic Reviews.
• Provide on-site support during the execution of validation protocols. Provide computer system validation training to other personnel, as applicable.
• Conduct Risk Assessments and participate in identifying the need for qualification and/or validation testing when implementing new software systems.
• Investigate and manage Deviations and CAPAs, and other quality system activities, including Periodic Reviews.
• Documenting activities following Good Documentation Practices (GDP), ensuring data integrity, system security, access control, and user safety are adequately addressed within validation documentation.

Qualifications:

• 10+ years of experience in FDA-regulated industries with strong knowledge of GMP, GAMP-5, 21 CFR Part 11, and Annex 11.
• 8+ years of experience in CSV document authoring, supporting SOP revisions, and protocol executions.
• Demonstrated ability to manage multiple concurrent validation or system implementation projects.
• Excellent written and verbal communication skills; strong collaborator with cross-functional teams.
• Self-motivated, adaptable, and customer-focused, with a proactive approach to leadership and problem-solving.
• Strong understanding of Good Documentation Practices and ALCOA+.

Education & Certifications:

• BS degree in science, engineering, computer science, or other science-related discipline.

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.