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Senior Life Sciences Supply Chain Manufacturing Ops – AI Transformation Delivery
EY. Assess manufacturing and quality workflows, user needs, system interfaces, equipment data, and current-state pain points through site observations, interviews, workshops, and data review .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in assessing and documenting manufacturing and quality workflows, with a strong focus on digital manufacturing solutions and compliance in regulated environments. Proficient in collaborating with cross-functional teams to implement MES/MOM systems and ensure data integrity and traceability.
Highest-signal resume keywords
MES/MOM ImplementationGxP ComplianceData Mapping and IntegrationFunctional and Integration TestingManufacturing Systems Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Process MappingRequirements DocumentationData Quality AssessmentConfiguration ManagementTest Script DevelopmentBatch and Equipment Data InterpretationAPI SpecificationsIndustrial ConnectivitySource-to-Target MappingsChange Control
Soft Skills
CollaborationCommunicationProblem-SolvingStakeholder EngagementTraining and Support
Tools & Technologies
LIMSQMSSCADADCS/PLCHistoriansConnected-Worker SolutionsAutomation SolutionsIndustrial Data PlatformsElectronic Batch RecordsPlant Performance Reporting
Certifications & Qualifications
Relevant Platform CertificationCloud CertificationData CertificationAutomation CertificationAgile Certification
Industry Keywords
Life Sciences ManufacturingPharmaceuticalBiotechnologyMedical DeviceRegulated EnvironmentGxPProcess Analytical TechnologyContinuous ImprovementRisk-Based Software AssuranceData-Integrity Controls
Tech Stack
Tools & technologiesCloudCyber SecurityERP
About the role
Key responsibilities & impact- Assess manufacturing and quality workflows, user needs, system interfaces, equipment data, and current-state pain points through site observations, interviews, workshops, and data review
- Document process flows, user stories, functional requirements, data mappings, interface requirements, controls, and acceptance criteria for digital manufacturing solutions
- Support design and implementation of MES/MOM, electronic batch records and eDHRs, recipe and routing management, batch and unit genealogy, review by exception, connected-worker workflows, and plant performance reporting
- Trace information across MES/MOM, ERP, LIMS, QMS, historians, SCADA, DCS/PLC, and asset-management platforms; identify data gaps and integration dependencies
- Develop and review equipment and batch hierarchies, source-to-target mappings, data-quality rules, and contextualized datasets
- Work with solution architects and engineers on interface specifications, APIs, industrial connectivity, and plant-edge-enterprise data movement
- Configure or prototype solution components and document design decisions
- Prepare and execute functional and integration test scripts, record defects, support resolution and retesting, and maintain requirements-to-test traceability
- Support deployment readiness, cutover, user training, hypercare, and handover
- Partner with quality and validation teams on GxP, data integrity, electronic records, change control, and computer system validation or risk-based assurance documentation
- Contribute to analytics and AI use cases by assessing source-data quality, defining manufacturing context, validating outputs, and documenting human-review needs
- Communicate progress, risks, dependencies, and recommended next steps to client counterparts and engagement leaders; coordinate defined tasks with junior colleagues
Requirements
What you’ll need- Bachelor's degree in engineering, life sciences, manufacturing, information systems, computer science, supply chain, or a related discipline
- At least 3 years of relevant experience in Life Sciences manufacturing, manufacturing systems, automation, industrial data, systems implementation, technology consulting, or a related field
- Experience working with manufacturing or quality processes in a pharmaceutical, biotechnology, medical-device, or comparably regulated environment
- Experience producing technical or functional delivery artifacts, such as requirements, process maps, data mappings, interface specifications, configuration documents, test scripts, or deployment materials
- Experience collaborating with both operational stakeholders and technical delivery teams to investigate requirements, resolve issues, or implement a solution
- Ability to travel as needed based on business and role requirements; travel can range from 80-100%
- Hands-on functional, configuration, integration, testing, or support experience with manufacturing, quality, laboratory, automation, or industrial-data solutions
- Ability to identify source systems, interpret batch and equipment data, document mappings and interfaces, investigate data-quality issues, and explain OT-to-enterprise information flows
- Understanding of regulated delivery, documentation, traceability, controlled changes, and reliable data for GxP activities
- Ideally: experience with MES/MOM, eBRs/eDHRs, recipe management, LIMS, QMS, historians, SCADA, DCS/PLC, connected-worker solutions, or industrial data platforms
- Ideally: familiarity with ISA-88/IEC 61512, ISA-95/IEC 62264, OPC UA, or MQTT/Sparkplug
- Ideally: exposure to GxP computer system validation, risk-based software assurance, data-integrity controls, electronic records, or OT cybersecurity
- Ideally: familiarity with Process Analytical Technology and continuous improvement practices
- Ideally: experience supporting manufacturing or quality analytics/AI use cases
- Ideally: relevant platform, cloud, data, automation, Agile, or manufacturing certification
Benefits
Comp & perks- Medical and dental coverage
- Pension and 401(k) plans
- Wide range of paid time off options
- Professional growth
- Inclusive culture
- Reasonable accommodation for qualified individuals with disabilities, including veterans with disabilities