Sr. CSV Engineer

Full Time Contract Title or Role: Senior Computer Systems Validation Associate Compensation: Up to $60/hr., commensurate with experience Location: Remote (Must be available to travel when validation protocol execution requires it) 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. As a Senior Associate, you will lead and be responsible for performing activities related to the Computer System Validation process for GAMP5 Category 3/4/5 GxP systems and qualification of GAMP5 Category 1 software tools. Working remotely, you will be involved in authoring and reviewing validation protocols, providing support for the change control process, reviewing vendor qualification documents, generating summary reports, performing periodic reviews, and supporting the CAPA process. During the execution process of protocols, you will be required on-site. 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.