The Principal Engineer & Support Manager is responsible for the strategic leadership, technical stewardship, operational excellence, and continuous improvement of Takeda's LabWare LIMS and MODA platform and associated laboratory informatics ecosystem.
Compensation
Competitive Salary + Performance Annual Bonus
Responsibilities
Serve as the principal technical authority for the LabWare LIMS and MODA platform
Define and maintain the LabWare and MODA technology roadmap aligned with DD&T and business objectives
Lead solution architecture, platform modernization, and integration strategy
Own the overall health, performance, scalability, and reliability of the LabWare ecosystem
Lead global support operations for LabWare and MODA systems
Seasoned individual contributor within the Supply Chain Technology function, Quality sub-function, accountable for the support, enhancement, and AI-enabled modernization of the enterprise quality systems landscape at DePuy Synthes.
Locations (5)
Raynham, Massachusetts, United States
West Chester, Pennsylvania, United States
New Brunswick, New Jersey, United States
Palm Beach Gardens, Florida, United States
Warsaw, Indiana, United States
Tech Professional, Quality Systems, AI
6084-Janssen Research & Development Legal Entity · Posted Nov 10, 2026
Seasoned individual contributor responsible for supporting, enhancing, and modernizing enterprise quality systems with AI and automation across DePuy Synthes.
IT Quality Specialist responsible for validation and quality activities for computerized systems in Roche’s Diagnostic division.
Compensation
The expected salary range for this position based on the primary location of California is $94,400-$175,200 of hiring range. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
Responsibilities
Coordinate and advise on all validation activities on a global/organizational level
Author and review various validation documentation and deliverables
Act as a CSV subject matter expert on project teams
Support system audit inspection readiness
Lead and author Computerized System Periodic Reviews
Requirements
Bachelor’s degree in science/engineering/computer science
Nice to have: Agile software development
Nice to have: Scrum
Nice to have: SAFe
Nice to have: Product Development Process for Medical Devices
Coordinate and advise on all validation activities on a global/organizational level for each assigned system/project, author and review validation documentation, support system audit inspection readiness, and lead Computerized System Periodic Reviews.
Compensation
The expected salary range for this position based on the primary location of California is $94,400-$175,200 of hiring range. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
Responsibilities
Coordinate and advise on all validation activities on a global/organizational level
Author and review various validation documentation and deliverables
Support system audit inspection readiness
Lead and author Computerized System Periodic Reviews
Assess changes to determine potential impact to the validated state of the computerized system
Requirements
Bachelor’s degree in science/engineering/computer science
Nice to have: Agile software development methodologies (Scrum and/or SAFe)
Nice to have: Product Development Process (PDP) for Medical Devices
Support the implementation and integration of a Laboratory Information Management System (LIMS) as a key link between QC business teams, IT, QA, and external system integrators.
Responsibilities
Translate User Requirement Specifications into practical system solutions
Conduct informal User Acceptance Testing to verify system functionality
Support IT and QA teams in delivering high-quality Functional and Design Specifications
Evaluate business criticality of Phase 2 requirements and recommend process improvements
Support system interface implementation and integration with MES, SAP, and CDS
Requirements
Bachelor's degree in science
Nice to have: Experience with LIMS implementation
Nice to have: Experience with LabVantage LIMS
Nice to have: Quality Control experience in a regulated environment
Lead Validation Engineer to support a major SCADA and Environmental Monitoring System modernization project at a regulated manufacturing facility in Southern California.
Responsibilities
Lead validation activities for SCADA, PLC, and Environmental Monitoring System upgrades.
Develop and execute validation documentation, including Validation Plans, URS, risk assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
Lead qualification of control systems, virtual infrastructure, servers, SQL databases, historian interfaces, and operator workstations.
Develop and execute risk-based testing for alarms, audit trails, user access, data integrity, backup/recovery, and system interfaces.
Support data migration, UAT, PQ, discrepancy resolution, and system release.
Support a pharmaceutical client as an Atlassian Administrator, managing Jira and Confluence tools, user accounts, permissions, workflows, and ensuring compliance with regulated environments.
Responsibilities
Administer and maintain Atlassian tools, primarily Jira and Confluence
Manage user accounts, groups, roles, permissions, and access rights
Configure and maintain Jira projects, workflows, issue types, screens, fields, and schemes
Manage Confluence spaces, permissions, templates, and content structures
Monitor system performance, troubleshoot issues, and provide technical support to users
Owns the technical integrity, standardization, and long-term health of the PharmaSuite solution that underpins the Next Generation Manufacturing Execution System.
Compensation
$144,000 - $231,000
Responsibilities
Drive standardization of manufacturing processes across sites
Define and maintain the global MES template
Partner with Technical Services & Manufacturing Technology, Process Engineering, Operations and Quality
Evaluate site requests for deviation from the standard
Establish and sustain the standards for Master Batch Record development
Requirements
Bachelor's degree in IT, Computer Science, Engineering, or equivalent
The anticipated base pay range for this position is : $96,000.00 - $155,250.00
Responsibilities
Provides day-to-day technical support for enterprise quality systems
Supports and enhances validated quality platforms covering complaint handling, CAPA, nonconformance, deviations, change control, document management, training records, and audit management
Identifies, evaluates, and delivers AI and automation use cases across quality processes
Partners with Data Science and AI teams to define data requirements, validate model outputs, and operationalize AI-enabled capabilities within quality workflows
Ensures AI and automation solutions applied to quality systems meet GxP, 21 CFR Part 11, and data integrity (ALCOA+) expectations
Requirements
Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or a related discipline
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