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Ernst & Young

Global professional services: consulting, assurance, tax

Life Sciences Supply Chain Manufacturing Operations and AI Transformation Delivery Senior

Implementation & Technical Account ManagementConfirmed live in the last 24 hours
Full-timeRemote in USA$97.3k - $202.6k

About the Job

Requirements

  • A 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%.
  • Knowledge of how production execution, batch records, equipment, materials, laboratory results, deviations, and quality review connect in a regulated plant.
  • Hands-on functional, configuration, integration, testing, or support experience with one or more 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 how information moves between OT and enterprise systems.
  • Ability to produce accurate requirements, design documents, test scripts, defect records, and deployment materials, and to follow issues through resolution.
  • Ability to discuss an operational problem with a plant user and document it clearly enough for a developer, data engineer, automation specialist, or tester to act on.
  • Understanding of why documentation, traceability, controlled changes, and reliable data matter when a solution supports GxP activities.
  • Curiosity about AI and advanced analytics, paired with the ability to test whether the underlying data, workflow, and proposed output are fit for use.

Responsibilities

  • 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 the design and implementation of capabilities such as manufacturing execution, electronic batch records and electronic device history records, recipe and routing management, batch and unit genealogy, review by exception, connected-worker workflows, and plant performance reporting.
  • Trace information across relevant systems, including MES/MOM, ERP, LIMS, QMS, historians, SCADA, DCS/PLC, and asset-management platforms; identify data gaps, inconsistent definitions, and integration dependencies.
  • Develop and review equipment and batch hierarchies, source-to-target mappings, data-quality rules, and contextualized datasets with manufacturing, automation, and data specialists.
  • Work with solution architects and engineers on interface specifications, APIs, industrial connectivity, and the movement of data between plant, edge, and enterprise environments.
  • Configure or prototype solution components where appropriate to experience and engagement, and document design decisions for review by technical and client leads.
  • Prepare and execute functional and integration test scripts, record defects, support resolution and retesting, and maintain traceability between requirements and test evidence.
  • Support deployment readiness, cutover, user training, hypercare, and handover by preparing technical documentation and responding to issues from plant users.
  • Partner with client quality and validation teams to prepare or review applicable documentation concerning GxP, data integrity, electronic records, change control, and computer system validation or risk-based assurance.
  • Contribute to analytics and AI use cases by assessing source-data quality, defining manufacturing context, checking outputs against operational workflows, and documenting where human review is needed.
  • Communicate progress, risks, dependencies, and recommended next steps to client counterparts and engagement leaders; coordinate defined tasks with junior colleagues when needed.

Desired Qualifications

  • Experience with MES/MOM, electronic batch records or eDHRs, recipe management, LIMS, QMS, historians, SCADA, DCS/PLC, connected-worker solutions, or industrial data platforms.
  • Experience examining manufacturing data from more than one source and relating it to assets, materials, products, orders, recipes, batches, or quality events.
  • Familiarity with ISA-88/IEC 61512 batch concepts, ISA-95/IEC 62264 manufacturing information models, or industrial connectivity approaches such as OPC UA and MQTT/Sparkplug.
  • Exposure to GxP computer system validation, risk-based software assurance, data-integrity controls, electronic records, or OT cybersecurity considerations relevant to the system being delivered.
  • Familiarity with Process Analytical Technology and continuous improvement practices, including using manufacturing data to monitor process performance, identify variability, and improve quality, throughput, and operational performance.
  • Experience supporting analytics or AI use cases in manufacturing or quality, such as process monitoring, predictive maintenance, deviation investigation, or decision support.
  • Experience with drug substance, drug product, biologics, sterile manufacturing, medical devices, or technology transfer.
  • Relevant platform, cloud, data, automation, Agile, or manufacturing certification.

About the Company

Ernst & Young

Global professional services: consulting, assurance, tax

EY (Ernst & Young) provides professional services at a global scale, offering consulting, assurance, tax, and transaction advisory services. It serves clients across industries such as technology, media, real estate, hospitality, and construction. Instead of selling a single product, EY works with clients through tailored engagements where cross-disciplinary teams analyze challenges, design strategies, perform audits, help with tax planning, and assist with mergers or divestitures. What sets EY apart is its worldwide reach and integrated service model, industry-specific expertise, and focus on responsible business practices like sustainability, cybersecurity, and workforce flexibility. EY’s goal is to help organizations improve performance, manage risk, and achieve sustainable growth while building a better working world.

Company size
5,001-10,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Boston, MA
Founded
1991

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