Location: Anywhere in Country
At EY, we're all in to shape your future with confidence.
We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world.
Role Snapshot
Client-facing Life Sciences manufacturing professional who helps design, build, test, and deploy digital solutions for regulated plant operations. The role combines practical knowledge of manufacturing processes with hands-on skills in manufacturing systems, industrial data, integration, analytics, and AI-enabled workflows.
The Opportunity
As a Senior in Supply Chain Manufacturing, you will work with pharmaceutical, biotechnology, and medical-device clients to connect production, quality, laboratory, engineering, and supply chain needs with deployable technology. You will contribute across the delivery lifecycle, from plant and system assessments through requirements, solution design, configuration support, testing, deployment, adoption, and stabilization.
You will work directly with operators, engineers, quality teams, IT and OT specialists, data teams, and technology providers. You will own assigned technical and functional deliverables, help resolve implementation issues, and make clear recommendations to your workstream lead. The role calls for someone who can examine a shop-floor workflow, trace the data and systems behind it, and turn what they learn into a design or testable requirement.
Your key responsibilities
In this role, you will:
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 (eDHRs), 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 proto@type solution components where appropriate to your experience and the 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 clear 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.
Skills and attributes for success
To thrive in this role, you should be able to work in depth in at least one technical area while collaborating across the broader manufacturing solution. You will bring:
Manufacturing and quality understanding: Knowledge of how production execution, batch records, equipment, materials, laboratory results, deviations, and quality review connect in a regulated plant.
Manufacturing technology skills: Hands-on functional, configuration, integration, testing, or support experience with one or more manufacturing, quality, laboratory, automation, or industrial-data solutions.
Data and integration skills: 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.
Delivery discipline: Ability to produce accurate requirements, design documents, test scripts, defect records, and deployment materials, and to follow issues through resolution.
Technical communication: 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.
Regulated-delivery awareness: Understanding of why documentation, traceability, controlled changes, and reliable data matter when a solution supports GxP activities.
Analytical judgment: Curiosity about AI and advanced analytics, paired with the ability to test whether the underlying data, workflow, and proposed output are fit for use.
To qualify for the role, you must have:
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%.
Ideally, you'll also have:
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 (PAT) and continuous improvement practices, including the use of 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.
What we look for
We are looking for a Senior who enjoys getting close to the manufacturing process and the technology that supports it. The strongest candidates ask precise questions, produce dependable technical work, recognize when data or design assumptions do not hold up, and collaborate well with plant, quality, and technology teams to make solutions usable in practice.
What we offer you
At EY, we harness our collective strength to empower you to shape your future with confidence through professional growth, personal fulfillment and an inclusive culture. Learn more at ey.com/us/careers .
The salary range for this job is:
New York City, Boston, and Washington DC Metro Areas, Washington State, and Southern California offices - $116,700 to $194,500
Bay Area California offices - $121,600 to $202,600
All other offices locations in the US, including Sacramento - $97,300 to $178,300
Individual salaries within these ranges are determined through a wide variety of factors including but not limited to education, experience, knowledge, skills and geography. In addition, our Total Rewards package includes medical and dental coverage, pension and 401(k) plans, and a wide range of paid time off options.
Are you ready to shape your future with confidence? Apply today.
To make the most of your application experience, please limit yourself to two applications within a six-month period.
EY accepts applications for this position on an on-going basis.
For those living in California, please click here for additional information.
At EY, our values set the foundation for how we work and the behaviors we expect of our people. Any misrepresentation or falsification of information or lack of integrity at any point in the recruiting process may result in withdrawal of your candidacy, revocation of an offer or immediate termination of employment.
EY | Building a better working world
EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets.
Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow.
EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories.
All in to shape the future with confidence.
EY provides equal employment opportunities to applicants and employees without regard to race, color, religion, age, sex, sexual orientation, gender identity/expression, pregnancy, genetic information, national origin, protected veteran status, disability status, or any other legally protected basis, including arrest and conviction records, in accordance with applicable law.?
EY is committed to providing reasonable accommodation to qualified individuals with disabilities including veterans with disabilities. If you have a disability and either need assistance applying online or need to request an accommodation during any part of the application process, please call 1-800-EY-HELP3, select Option 2 for candidate related inquiries, then select Option 1 for candidate queries and finally select Option 2 for candidates with an inquiry which will route you to EY's Talent Shared Services Team (TSS) or email the TSS at ssc.customersupport@ey.com .
