Digital Quality Engineer

Own the lifecycle management, validation, and sustained operation of digital quality systems and related capabilities. Serve as the Quality subject-matter expert and system owner for digital quality technologies, ensuring solutions are compliant, fit for purpose, inspection-ready, and aligned with cGMP, data integrity, and electronic records/electronic signatures requirements.​
Responsibilities
​​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.

Employment type
Full-time

Work arrangement
No