Lead Engineer, IT Compliance, Data Integrity

Bristol Myers Squibb • Bothell, WA

1d

About The Position

The Lead Engineer, IT Compliance, Data Integrity is an individual contributor in Bristol Myers Squibb’s Cell Therapy Information Technology organization, supporting the Bothell, Washington manufacturing site. The position applies technical expertise to the compliance, integrity, validation, and continuous improvement of GxP computerized systems. It also contributes to organizational learning, technology adoption, workforce capability development, and digital transformation initiatives. The role collaborates with IT, Quality, Manufacturing, Engineering, Supply Chain, and Validation teams in a highly regulated pharmaceutical manufacturing environment. It has no direct people-management responsibilities.

The position leads and supports compliance programs, risk assessments, investigations, validation, audits, and inspection readiness for computerized systems used in manufacturing, quality, laboratory, and business operations. It also develops learning and competency programs, supports technology-enabled learning and organizational change, facilitates cross-functional improvement work, and uses research and data analysis to evaluate learning effectiveness, organizational performance, compliance trends, technology adoption, and improvement opportunities. The role mentors colleagues and provides subject matter expertise in compliance, organizational learning, human performance improvement, and digital transformation.

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.
• Experience with IT compliance applications and systems in a biotech manufacturing environment.
• At least 5 years of hands-on experience in a biotech manufacturing and supply chain environment.
• Understanding of supply chain and manufacturing domains and supporting technology, including manufacturing and supply chain ERP systems, process automation, and historians.
• Knowledge of cGMP, GxP, GAMP, SDLC regulations, including 21 CFR Part 11, and good documentation practices.
• Knowledge of industry-standard quality and compliance methodology for ensuring IT systems meet intended performance and regulatory requirements.
• Understanding of computer system validation and SDLC methodologies.
• Ability to communicate effectively with technical and non-technical team members.
• Ability to define and implement solutions for complex, ambiguous challenges aligned with team priorities.
• Exceptional interpersonal skills, particularly teamwork, collaboration, client focus, and verbal and written communication.
• Exceptional technical and problem-solving skills and the ability to work independently.
• Demonstrated success working in a high-performing, business results-driven environment.
• Knowledge of pharmaceutical, manufacturing, and laboratory systems and equipment supporting biologics and clinical manufacturing.
• Experience leading or supporting root cause analysis and investigations, QRAs, DIRAs, change control and change management, CAPA and deviation management, internal audits and self-inspections, CSV, and regulatory inspection readiness.

Nice To Haves

• Master’s or doctoral degree in Education, Organizational Leadership, Learning & Development, Business Administration, Engineering, Information Technology, Pharmaceutical Sciences, or a related discipline.
• Current enrollment in or completion of an EdD, Organizational Leadership, Learning Sciences, or related doctoral program.
• Experience designing and delivering organizational learning, training, curriculum development, leadership development, or workforce capability programs.
• Experience applying adult learning principles, instructional design methodologies, and performance improvement frameworks.
• Experience conducting quantitative research, program evaluations, data analysis, or applied organizational research.
• Experience leading digital transformation initiatives, technology adoption programs, or AI-enabled learning solutions.
• Experience with Manufacturing Execution Systems (MES), eQMS platforms, ServiceNow, SAP, Oracle, Agile/JIRA, laboratory systems, or electronic batch record systems.
• Experience in Cell Therapy, Gene Therapy, or Biologics manufacturing environments.

Responsibilities

• Lead IT compliance and data integrity programs for GxP computerized systems supporting 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, CAPA development, and effectiveness monitoring using structured problem-solving methodologies.
• Support computerized system validation 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.
• Lead internal audits, self-inspections, data integrity assessments, and regulatory inspection readiness, ensuring timely remediation of findings.
• Develop and implement training strategies, competency frameworks, and learning programs supporting compliance, technology adoption, and workforce development.
• Design and evaluate instructional materials, learning pathways, job aids, and digital training solutions to improve employee performance and operational effectiveness.
• Partner with stakeholders on technology-enabled learning initiatives, including AI, automation, and digital solutions that enhance user experience and compliance outcomes.
• Apply change management principles to support organizational readiness, stakeholder engagement, user adoption, and sustainable implementation of technologies and business processes.
• Facilitate workshops and cross-functional teams focused on innovation, continuous improvement, and design-thinking approaches to complex business and compliance challenges.
• Conduct applied research and quantitative analysis to evaluate learning effectiveness, organizational performance, compliance trends, technology adoption, and process improvement opportunities.
• Develop performance metrics, dashboards, and data-driven recommendations to support strategic decision-making and resource planning.
• Mentor team members and provide leadership in compliance, organizational learning, human performance improvement, and digital transformation.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
• Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
• Paid vacation for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
• 11 paid company holidays each year.
• Three optional holidays for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees.
• Potential eligibility for additional discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior