Digital Quality Engineer

📋 Description

• Lead Quality ownership of digital quality systems, including implementation, enhancement, lifecycle
• Act as the Quality system subject-matter expert, translating business, cGMP, data integrity, and
• Partner with Quality, Manufacturing, IT, Engineering, Validation, and other stakeholders to define
• Own or coordinate Quality input to software and computer system validation activities, including
• Ensure systems and associated processes support accurate, complete, consistent, contemporaneous
• Lead Quality review and approval of system changes, releases, access controls, and periodic

🎯 Requirements

• Bachelor’s degree in engineering, computer science, life sciences, or a related technical
• 5+ years of relevant experience in pharmaceutical, biotechnology, or other regulated manufacturing
• Experience with quality management systems, electronic records systems, manufacturing or laboratory
• Experience with software or computer system validation, including risk-based validation
• Excellent written and verbal communication skills, with the ability to develop clear procedures
• Ability to work independently, prioritize effectively in a dynamic project environment, and

🎁 Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs