Senior Engineer, QA Validation - Remote

Overview

The Senior Engineer, QA Validation is responsible for Quality Assurance Validation oversight of Computer Systems and Analytical instruments Validation, guiding the plan and design phase of projects and continuous process improvements in manufacturing and lab environments.

In Short

• Provide Quality Assurance expertise and oversight for Computer Systems Validation (CSV).
• Drive Computer Software Assurance (CSA) approach, including risk assessments.
• Guide QA oversight for Software Development Life Cycle (SDLC) documents.
• Support Quality Change Management processes.
• Conduct investigations and root cause analysis on discrepancies.
• Author Periodic Review Reports for computerized systems.
• Represent QA Validation in multi-departmental meetings.
• Contribute to the CSV functional strategies and long-term roadmap.
• Participate in computerized system audits.
• Manage CSV activities and resources.

Requirements

• BS in IT/IM/Computer Science or Engineering field.
• 8 to 10 years’ experience in CSV in the Life-science/regulated industry.
• 3 to 5 years’ experience in Analytical Instruments validation.
• Experience in Deviations, CAPAs, and Change Control Management.
• Strong knowledge of FDA regulations and industry standards.
• Experience with Data Integrity requirements.
• Strong decision-making and critical thinking skills.
• Experience with Veeva QMS and Quality Docs.
• Experience with automation applications like SCADA and DeltaV.
• Other duties as assigned.

Benefits

• Hybrid working model with flexibility for onsite presence.
• Opportunity for travel for conferences and global alignment initiatives.
• Work in a cutting-edge biotechnology environment.
• Be part of a team that develops transformative medicines.