Senior CSV Specialist – Remote Validation for GxP Systems

RCM Technologies, Inc.; United States; Híbrido; USD 68.000 - 97.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

CSV leadership

GxP knowledge

21 CFR Part 11

Annex 11

Communication

Cross-functional

Educación

BS degree in science/engineering/CS

Herramientas

GDP/ALCOA+

Descripción del empleo

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.