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
Supervisor of Quality Control (QC) Lab Operations to support a highly automated drug substance manufacturing facility.
Compensation
$80,300.00 - $131,300.00
Responsibilities
Hire, onboard, and develop team; define individual development plans tied to technical and leadership competencies
Set goals, provide ongoing coaching and feedback, and conduct performance reviews; address performance gaps through documented coaching and improvement plans
Maintain training compliance for direct reports and a team skills matrix covering equipment qualification, CSV, LIMS and CDS integration, and GMP document authorship
Maintain the integrated portfolio of lab builds, technology implementations, and upgrades scope, schedule, resource loading, and cross-project dependencies
Review scoping and business cases developed by the team; recommend prioritization and funding requests to QC management
Requirements
BS/BA in Life Sciences, Chemistry, or Engineering discipline
Provide technical expertise and ownership for the implementation of Manufacturing Execution System (MES) and electronic Batch Records (eBR) for one manufacturing line.
Compensation
€66,918.00 - €112,600.00
Responsibilities
Lead and support MES/eBR implementation across requirements, design, configuration/development, testing, qualification and rollout.
Translate manufacturing process and user requirements into robust MES/eBR functional and technical solutions.
Design, configure and maintain electronic batch records (eBRs) in accordance with manufacturing, quality, regulatory and business requirements.
Ensure harmonization and reuse of existing MES standards, templates and solutions, while addressing RPP5-specific manufacturing requirements.
Define, coordinate and support interfaces between MES and connected manufacturing/enterprise systems, such as SAP, automation/process control systems and other relevant production systems.
Requirements
Bachelor's or Master's degree in IT, Engineering, Automation, Manufacturing Technology or a comparable technical discipline, or equivalent technical education combined with relevant professional experience.
Nice to have: PAS-X
Nice to have: pharmaceutical MES/eBR platform
Nice to have: SAP integration
Nice to have: automation/process control systems (PLC/PCS)
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