Systems Quality Engineer

​​Lead Quality ownership of digital quality systems, including implementation, enhancement, lifecycle management, and operational support for quality-related capabilities. 

​Act as the Quality system subject-matter expert, translating business, cGMP, data integrity, and electronic records/electronic signatures requirements into clear system requirements and operational controls. 

​Partner with Quality, Manufacturing, IT, Engineering, Validation, and other stakeholders to define, configure, test, deploy, and sustain compliant digital solutions. 

​Own or coordinate Quality input to software and computer system validation activities, including risk assessments, requirements, test strategy, test execution, traceability, defect resolution, and validation deliverables, as applicable. 

​Ensure systems and associated processes support accurate, complete, consistent, contemporaneous, and attributable electronic data and records throughout the data lifecycle. 

​Lead Quality review and approval of system changes, releases, access controls, and periodic assessments through established change-control and quality-system processes. 

​Support investigation and resolution of system-related deviations, incidents, data-integrity events, and CAPAs; assess product-quality and compliance impact and drive timely, effective actions. 

​Develop and maintain procedures, work instructions, training materials, and role-based training to promote compliant and effective use of digital quality systems. 

​Monitor system performance, user feedback, and emerging compliance needs; identify and implement continuous improvements in partnership with functional stakeholders. 

​Maintain inspection readiness by providing system expertise, validation evidence, traceability, and clear responses to internal audits, regulatory inspections, and health-authority inquiries.​ 

​​Bachelor’s degree in engineering, computer science, life sciences, or a related technical discipline; advanced degree preferred. 

​5+ years of relevant experience in pharmaceutical, biotechnology, or other regulated manufacturing environments, including Quality, Manufacturing, digital systems, or validation. 

​Experience with quality management systems, electronic records systems, manufacturing or laboratory systems, or comparable GxP digital platforms strongly preferred. 

​Experience with software or computer system validation, including risk-based validation, requirements, testing, traceability, and validation documentation, preferred; ability to be accountable for validation activities as needed. 

​Excellent written and verbal communication skills, with the ability to develop clear procedures, training, and inspection-ready documentation. 

​Ability to work independently, prioritize effectively in a dynamic project environment, and influence stakeholders without direct authority.