Lead IT Compliance & Data Integrity Engineer

Bristol Myers Squibb; Bothell (WA); On-site; USD 118,000 - 143,000; Full time

Benefits offered by this job

Wellbeing benefits

Retirement plan

Insurance (medical, dental, vision)

Paid holidays

Flexible Time Off

Job summary

Bristol Myers Squibb seeks a Lead Engineer, IT Compliance, Data Integrity for its Bothell, WA site. You will drive GxP IT compliance, data integrity, and validation programs across manufacturing, quality, and operations, collaborating with IT, QA, Manufacturing, and Validation teams in a highly regulated environment.

The role emphasizes cross-functional collaboration, learning, and digital transformation initiatives, with a focus on regulatory readiness and continuous improvement.

Qualifications

• Bachelor's degree in IT/Engineering/Life Sciences or related field.
• 5+ years in biotech manufacturing and supply chain environment.
• Experience with IT compliance applications and systems in bio-tech manufacturing.
• Knowledge of cGMP, GXP, GAMP, SDLC and 21CFR part 11.

Responsibilities

• Lead IT compliance and data integrity programs for GxP systems in Cell Therapy operations.
• Manage Data Integrity Risk Assessments (DIRAs) and Quality Risk Assessments (QRAs).
• Oversee investigations, root cause analyses, CAPA development and monitoring.
• Support validation activities across system lifecycle including CSV.
• Conduct change control assessments and regulatory inspection readiness.
• Develop training strategies and learning programs for compliance and digital transformation.
• Lead internal audits and self-inspections; ensure timely remediation of findings.

Education

Bachelor's degree in IT/Engineering/Life Sciences

Tools

GxP systems

CSV/validation

Regulatory compliance

Job description

Bristol Myers Squibb seeks a Lead Engineer, IT Compliance, Data Integrity for its Bothell, WA site. You will drive GxP IT compliance, data integrity, and validation programs across manufacturing, quality, and operations, collaborating with IT, QA, Manufacturing, and Validation teams in a highly regulated environment.

The role emphasizes cross-functional collaboration, learning, and digital transformation initiatives, with a focus on regulatory readiness and continuous improvement.