Smart Manufacturing Systems Analyst

GlaxoSmithKline; United States; On-site; USD 110,000 - 150,000; Full time

Job summary

GlaxoSmithKline is seeking a Smart Manufacturing Systems Analyst to design and implement digital solutions on the site. You will lead requirements, design workflows, and coordinate cross‑functional teams to improve Right-First-Time performance and data-driven decision making across Operations, Quality, and Supply Chain.

You will validate, deploy, and support MES/eBR and low-code tools, ensuring GMP compliance and robust data flows, with a focus on continuous improvement and AI-enabled digital

Qualifications

• Associate degree in a technical field; or 12+ months co-op/industry experience in digital systems.
• 3+ years in regulated manufacturing with Smart Manufacturing or digital systems experience.
• Experience documenting user/business requirements and creating design docs.
• Knowledge of GMP and validation for computerized systems.
• Proficiency with Visio, Excel, and 365 apps; strong written/verbal communication.

Responsibilities

• Lead cross-functional teams to elicit requirements and translate into system workflows.
• Design, configure, test, and deploy Smart Manufacturing solutions and integrations.
• Validate solutions against GMP, regulatory, and user requirements before go-live.
• Create GMP docs: URDs, DSs, test plans, validation records, SOPs, user guides.
• Support deployment, training, and shop-floor adoption; provide BAU support.
• Develop intuitive data visualizations for quick decision-making.

Skills

Business analysis

Stakeholder management

Process mapping

GMP knowledge

Data visualization

Education

Associate degree in Engineering/CS/IS

4+ years pharma/manufacturing experience

Tools

Power BI

MS Visio

Excel/M365

Job description

The Smart Manufacturing Systems Analyst is responsible for the design, implementation, lifecycle support, ancontinuous improvement of Smart Manufacturing solutions at the site. The role delivers value by improving Right-First- Time performance, reducing manufacturing and review lead times, increasing digital adoption on the shop floor, and enabling data-driven decision-making across Operations, Quality, and Supply Chain. The role partners with Process Owners, Operations, Quality, Tech, Automation, Global Teams, and Smart Manufacturing leadership to understand manufacturing processes and user needs and translate them into robust, user- centered digital workflows and system solutions. Working within multidisciplinary teams, the Smart Manufacturing Systems Analyst supports the full solution lifecycle, from requirements elicitation and process analysis through system design, configuration, integration, testing, validation, deployment, business-as-usual support, and continuous improvement. The scope includes electronic batch records in the MES, as well as other Smart Manufacturing systems such as low- code applications, electronic checklists and logbooks, scheduling and optimization solutions, process-data platforms, system integrations, analytics, and data visualization products. The role applies an AI-first and digital mindset, using enterprise AI-enabled tools and Smart Manufacturing learning pathways to improve productivity, business outcomes, quality of deliverables, knowledge sharing, and ways of working across the site.

Responsibilities

• Lead cross-functional teams to elicit, understand, and document business and user requirements, and translate business processes into clear, actionable system workflows.
• Partner with global and local teams, ask the right questions, and remove roadblocks to translate shop-floor needs into actionable requirements that can be used for system design.
• Act as system designer for assigned Smart Manufacturing solutions.
• Translate documented workflows into robust, user-centered system designs and configured solutions across relevant Smart Manufacturing platforms, ensuring alignment with local and global functional, business, and GMP requirements.
• With support from Tech and Automation, design and maintain integrations among Smart Manufacturing systems and with connected enterprise and automation systems, including MES/eBR, data historians, automation/SCADA systems, SAP ERP, and other digital manufacturing tools, ensuring reliable data flows and robust execution of business rules and automated checks.
• Identify applicable use cases and define testing strategies to confirm that solutions perform as intended before deployment.
• Define and/or create the master data needed to support testing, deployment, and accurate system configuration.
• Create and maintain GMP documentation, including user requirements, design specifications, test documentation, and validation records, to support the implementation and lifecycle management of Smart Manufacturing systems.
• Execute validation testing to confirm that digital solutions meet approved user, business, functional, and regulatory requirements before go-live.
• Support system deployment and go-live activities, including dry‑runs, end‑user training, troubleshooting, and shop‑floor support, to enable effective adoption and a smooth transition to new or updated systems.
• Manage business‑as‑usual support and drive data‑informed continuous improvement of assigned systems.
• Perform Gemba walks, proactively collect user feedback, and use operational data to identify and implement improvements that keep solutions effective and fit for purpose.
• Partner with business owners and user groups to identify the data needed to support operations and decision‑making and develop intuitive data visualization products that provide quick and easy access to actionable information.

Why You?

Basic Qualification

• Associate’s degree in Engineering, Computer Science, Information Systems, Industrial/Manufacturing Engineering, Automation or related technical discipline
• 3+ years of experience in pharmaceutical, biopharmaceutical, or other regulated manufacturing environments, and at least one year of experience designing Smart Manufacturing or Digital Systems solutions.
• Or 12+ months of combined co‑op, internship, or industry experience in a manufacturing, engineering, automation, or digital systems setting, including hands‑on contribution to a digital, data, or automation project.
• Design, configure, test, deploy, support, and continuously improve Smart Manufacturing solutions in a manufacturing GMP‑regulated environment.
• Experience supporting project execution, testing, and validation of computerized or digital systems in a GMP‑regulated environment.
• Knowledge of manufacturing operations and GMP production processes, with the ability to understand shop‑floor needs and their application to digital‑system design.
• Experience to elicit and document user and business requirements, facilitate process mapping, and translate manufacturing processes and user needs into clear, user‑centered system workflows and digital solutions.
• Experience to lead cross‑functional discussions and communicate effectively between business and technical stakeholders, translating shopfloor and business language into actionable technical requirements and explaining technical concepts in clear business language.
• Experience in technical writing and preparation of controlled documentation, including user requirements, design documentation, test and validation records, incident reports, SOPs, user guides, and training materials.
• Proficiency with tools used to document and analyze requirements, processes, and workflows, including Microsoft Visio, Excel, and related Microsoft 365 applications.
• Experience with data visualization or analytics tools, such as Power BI, Power Apps, PI Vision, Spotfire, or equivalent solutions, and the ability to present operational information clearly and intuitively to support decision‑making.
• Collaboration and stakeholder‑management skills across Operations, QA, Tech, Automation, Process Owners, Smart Manufacturing, and global teams.

Preferred Qualification

• Bachelor’s or Master’s degree in Engineering, Computer Science, Data/Analytics, Industrial/Manufacturing Engineering, Automation or related field.
• Ability to operate independently in a complex matrix environment, manage competing priorities, and maintain a strong focus on deliverables, business outcomes, quality, and continuous improvement.
• Demonstrated learning agility, curiosity, and adaptability, with the ability to quickly develop proficiency in new digital systems and emerging technologies and apply them to solve business and manufacturing problems.
• Experience designing electronic batch records using Siemens OpCenter Execution Pharma or a comparable Manufacturing Execution System.
• Experience with low‑code platforms (e.g. Mendix), digital logbooks, manufacturing scheduling or optimization solutions, data historians, or other Smart Manufacturing technologies.
• Basic scripting or programming experience, such as Python or a similar language, and a foundational understanding of relational databases, data models, or time‑series data structures.
• Experience working in Agile, iterative, or product‑centric delivery teams, including backlog refinement, minimum viable product definition, incremental deployment, and data‑informed continuous improvement.
• Demonstrated ability to influence across organizational boundaries, navigate complex or competing stakeholder needs, and facilitate alignment between local and global teams.
• Champion an AI‑first and digital mindset, with experience using AI‑enabled, LLM tools to improve productivity, quality, knowledge management, and ways of working.

Skills

• Business Analysis
• Business Requirements Analysis
• Data Validation
• Decision Making
• Project Scoping
• Stakeholder Management

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.

We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.

We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines.

We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most.

Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - [e-mail]

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.

All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/.

We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.