CSV Engineer

CSV Engineer

Overview

Join our team as a Computer System Validation Engineer, where you'll play a crucial role in ensuring the reliability and compliance of critical systems like Empower3 and LabX. Your work will directly support our mission to produce essential medications, offering you the chance to lead projects, optimize systems, and make a significant impact on public health.

Responsibilities

• Oversee the validation of laboratory systems, ensuring they meet Good Automated Manufacturing Practice (GAMP 5), FDA data integrity standards, and 21 CFR Part 11 regulations.
• Develop, execute, and review protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to ensure compliance with regulatory and internal standards.
• Lead validation projects, working closely with teams from Quality Operations, Quality Assurance, Quality Control, IT, and Operations to ensure tasks are completed on time and in compliance.
• Perform risk assessments using methodologies like Failure Mode and Effects Analysis (FMEA) to enhance system reliability and compliance.
• Provide expertise during the implementation and modification of systems, maintaining their validated status and continuously improving validation processes.

Skills and Knowledge

• Strong organizational, problem-solving, and project management abilities, with a talent for managing complex projects and collaborating across diverse teams.
• Proficiency in systems like Empower3, LabX, SCADA, and enterprise systems for CMMS, QMS, EMS, and BMS. In-depth knowledge of GAMP 5, FDA data integrity, 21 CFR Part 11, and validation principles, along with strong regulatory compliance and Microsoft Office skills.

Experience and Qualifications

• 5+ years of experience in Computer Systems Validation, with a focus on manufacturing/laboratory systems
• Bachelor's degree in a scientific or engineering field required