We are seeking a Validation Consultant to become an integral part of our team! You will service domestic
and international clients, as well as support in-house software.

Responsibilities:
• Assist our clients with the development, revision, and review of written procedures for system
administration of GxP systems in both Laboratory and manufacturing areas.
• Support implementation of new solutions, testing, management, troubleshooting, and administration of
new and existing systems within a Pharmaceutical lab environment which include but not limited to
Chromatography Data Systems such as Empower, UV-Vis, GCMS, FTIR, LIMS, Mastersizer and other
standalone equipment.
• Independently perform evaluation of applications, instruments and equipment for 21 CFR Part 11
identify gaps, implement corrective actions.

Qualifications:
• Must have minimum of 5 years experience in Computer System Validation, or related disciplines.
• Strong computer, scientific, and organizational skills
• Strong root-cause analysis skills
• Deadline and detail-oriented
• Knowledge of 21 CFR Part 11 requirements and data integrity
• Knowledge of risk-based Change Management and Quality Management systems.
• The candidate must have strong communication skills.
• Must be able to travel within north America and abroad.
• Knowledge of 21 CFR Part 11 requirements and data integrity
• Knowledge of risk-based Change Management and Quality Management systems.