Engineer - Quality - Global CSQA

Role Summary

The Engineer - Quality - Global Computer Systems Quality Assurance (CSQA) role is responsible for ensuring that their assigned functional areas, projects and/or systems comply with corporate computer system validation (CSV) standards. This includes providing consultation and interpretation of Corporate Computer Systems Standards, Practices, and Procedures, providing oversight for CSV execution (including approving CSV documents per corporate standards/practices), maintaining awareness of corporate and external standards as they relate to CSV, and assurance of inspection readiness within supported areas. While the primary area of responsibility for this position will be as aligned with Information Systems Quality (ISQ) needs, it is intended to include a significant portfolio within the Manufacturing and Quality organization. Preference will be given to candidates who can demonstrate strength, technical knowledge and proficiency in those subject matter areas (e.g., manufacturing execution systems, laboratory information management systems, quality systems, etc.).

Responsibilities

• Maintain Inspectional Readiness: Ensure supported systems are validated in compliance with applicable standards and procedures
• Maintain and track all quality actions and commitments for supported areas
• Participate in self-inspections, audits, and supplier assessments to ensure clear understanding of computer system validation status
• Ensure Inspection Readiness materials are current and appropriate
• Provide periodic updates to key stakeholders
• Escalate issues appropriately

Responsibilities

• Deliver Projects, Programs, And Support: Provide consultation and interpretation on policies and procedures related to the supported computer system
• Provide training to customer areas on CSV-related topics as needed
• Partner with Business, Business Quality, and IT customer areas to deliver business value
• Understand customer, company, and Quality priorities
• Review/approve documents per CSV expectations within agreed service levels, or clearly communicate when activities will be completed
• Engage customers and Quality Assurance management in risk management discussions
• Ensure suppliers of computer systems or services meet quality expectations
• Escalate computer system quality issues appropriately
• Strive for and promote consistency within the CSQA organization

Responsibilities

• Streamline And Continuously Improve: Eliminate non-value-added activities to focus on quality assurance improvements; engage in process improvement projects
• Identify opportunities for streamlining and simplification; assist in developing improved solutions
• Understand external trends and potential ramifications for the supported IT area(s)

Responsibilities

• Grow Capabilities And Knowledge: Share lessons learned and best practices; support teammates by sharing experience and providing backup coverage

Qualifications

• Required: Bachelor’s degree in a technology-related field such as Computer Science
• Required: 5+ years’ experience in IT, Automation, or computer system validation
• Preferred: Understanding of process development and/or improvement (e.g., Six Sigma)
• Preferred: Experience conducting risk assessments, self-inspections, audits and/or supplier assessments
• Preferred: Strong oral and written communication and presentation skills
• Preferred: Influence and mentoring skills with peers and management
• Preferred: Proficiency with IT systems development life cycle
• Preferred: Proficiency with Microsoft Office products
• Preferred: Experience with Computer Systems Validation
• Preferred: Prior IT system development or QA experience
• Preferred: Competency in IT technical disciplines (e.g., Information Security, Programming, Data Analytics, Cloud)
• Preferred: Knowledge of IT Best Practices (e.g., COBIT, ITIL, GAMP)
• Preferred: IT-control related certifications (e.g., CISA, ISO, ITIL, CSQE)

Education

• Bachelor’s degree in a technology-related field such as Computer Science