- Bothell, Washington, United States
- On-site
- Full-time · Senior
- $118K–$143K per year
- 5+ years
Lead Engineer, IT Compliance, Data Integrity is an individual contributor within the Cell Therapy Information Technology organization supporting Bristol Myers Squibb's Bothell, WA manufacturing site.
Compensation
Bothell - WA - US: $118,280 - $143,325
Responsibilities
- Lead IT compliance and data integrity programs supporting GxP computerized systems used in Cell Therapy manufacturing, quality, laboratory, and business operations.
- Facilitate and oversee Data Integrity Risk Assessments (DIRAs), Quality Risk Assessments (QRAs), system impact assessments, and compliance evaluations.
- Lead complex investigations, root cause analyses, deviation management activities, CAPA development, and effectiveness monitoring using structured problem-solving methodologies.
- Support computerized system validation activities throughout the system lifecycle, including risk assessments, validation strategies, protocol reviews, implementation support, and periodic reviews.
- Conduct compliance assessments and change impact evaluations for system upgrades, enhancements, infrastructure changes, and digital transformation initiatives.
Requirements
- Bachelor's degree in Information Technology, Chemical, Engineering, Computer Science, Life Sciences, Biotechnology, Pharmaceutical Sciences, Education, Organizational Development, Business Administration, or a related field.
- Nice to have: Master's degree or Doctoral degree in Education, Organizational Leadership, Learning & Development, Business Administration, Engineering, Information Technology, Pharmaceutical Sciences