Batch Record Reviewer Jobs in Raleigh, NC (NOW HIRING)

The MES Solutions Specialist is responsible for the design, configuration, testing, deployment, maintenance, and continuous improvement of Manufacturing Execution System (MES) solutions supporting GSK Zebulon manufacturing operations.
The role has primary responsibility for the development and lifecycle management of Electronic Batch Record System (eBRS) workflows, ensuring compliant, reliable, and efficient execution of manufacturing processes. Responsibilities include requirements gathering, solution design, configuration, validation support, deployment, troubleshooting, and ongoing operational support.
The role also provides business and functional support for additional MES applications, including Weigh & Dispense, In-Process Checks (IPC), and Serialization. Working closely with MSAT, Manufacturing, Quality, Engineering, Supply Chain, Digital, and other stakeholders, the MES Solutions Specialist translates approved recipes, batch document designs, and manufacturing requirements into effective MES workflows that support compliance, data integrity, operational efficiency, and Smart Manufacturing objectives.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Support day-to-day MES operations, including incident support, user access, reporting, troubleshooting, and timely escalation of issues.
• Design, configure, test, deploy, maintain, and continuously improve eBRS workflows supporting approved manufacturing processes.
• Engage with stakeholders and end users to understand needs, develop user requirements, improve user experience, and translate approved recipes, batch record designs, and business requirements into compliant MES solutions.
• Collaborate with other sites to contribute, share, and leverage best practices for MES solution delivery and support.
• Develop and maintain MES content, including workflows, electronic forms, master data, system configurations, and supporting documentation; develop less complex workflows and support implementation of more complex solutions delivered by external development partners.
• Review externally developed solution designs and technical deliverables, and coordinate external resources, to confirm alignment with approved requirements, site standards, data integrity expectations, delivery timelines, and MES best practices.
• Manage technical change control activities, including associated documentation, system move activities, implementation, and related standard operating procedures.
• Execute and document informal testing, user acceptance testing, and formal validation testing, including process qualification as applicable, for MES workflows and system changes of varying complexity.
• Support MES validation and governance activities, including requirements traceability, risk assessments, defect management, periodic validation reviews, periodic access reviews, investigations, deviations, CAPAs, corrective actions, and associated quality documentation.
• Provide functional support for additional MES applications, including Weigh & Dispense, In-Process Checks, and Serialization, and support acceptance of externally delivered solutions through deliverable reviews and completion recommendations
• Responsible for the successful design, development, testing, deployment, support, and continuous improvement of MES solutions supporting GSK Zebulon manufacturing operations.
• Serves as the functional owner for assigned MES content and workflows, ensuring alignment with approved business requirements, manufacturing process designs, data integrity principles, regulatory expectations, site standards, and operational needs.
• May assist with the scoping, coordination, and oversight of up to five contracted resources or Statement of Work workers supporting MES solution delivery. Responsibilities may include assigning or coordinating work, reviewing solution designs, validating delivered functionality, monitoring milestones, coordinating testing, and participating in deliverable acceptance.
• Provides recommendations regarding completion of contracted work and associated vendor invoice approvals but does not have direct budget ownership or formal personnel-management responsibility

Why You?
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor's degree or an equivalent combination of education and relevant professional experience.
• Experience supporting, configuring, testing, or deploying Manufacturing Execution Systems or comparable manufacturing software platforms.
• Experience gathering functional requirements and translating them into system configurations, workflows, or technical solutions.
• Experience executing software testing, troubleshooting, and deployment activities in a regulated environment.
• Experience working within cross-functional teams supporting manufacturing, quality, engineering, technical, or supply chain operations.
• Experience with change control, computerized system validation, data integrity, and quality processes associated with GxP systems.
• Experience supporting system incidents, deviations, investigations, CAPAs, or other problem-solving activities.
• Experience coordinating work performed by external vendors, contractors, consultants, or development partners.
• Working knowledge of Manufacturing Execution Systems, Electronic Batch Record Systems, and related manufacturing technologies.
• Understanding of software development lifecycle, validation lifecycle, change control, and system lifecycle management in regulated environments.
• Knowledge of GxP principles, data integrity requirements, electronic records, electronic signatures, and computerized system compliance expectations.
• Experience in translating approved recipes, batch documents, process requirements, and user needs into effective MES workflow designs.
• Experience in reviewing functional requirements, solution designs, test evidence, and software deliverables for completeness and quality.
• Have experience to execute and document informal testing, user acceptance testing, and formal validation testing.
• Experience with MES functionality, workflow design, business-process integration, data integrity controls, and validation evidence to technical, operational, quality, leadership, and regulatory audiences.
• Support continuous improvement through effective use of digital manufacturing technologies.

Preferred Qualification
If you have the following characteristics, it would be a plus:

• Knowledge of MS Windows Operating Systems, MS SQL Server Databases
• Experience working in, or directly supporting, GMP production operational processes.
• Strong relationship-building and stakeholder-management skills.
• High learning agility - ability to learn and adapt to new concepts, systems, and software independently and quickly.
• Basic understanding of the following: Cyber protection and data privacy concepts; automation and automated process control systems; wireless standards/protocols/technologies.
• Experience configuring, testing, or supporting eBRS solutions in a regulated manufacturing environment.
• Experience with automated software testing and test script management tools, such as OpenText UFT (formerly Micro Focus or HP UFT) or comparable platforms.
• Experience using Kneat or a comparable digital validation platform.
• Working knowledge of SAP manufacturing, quality, materials management, or supply chain processes.
• Experience using Microsoft Azure DevOps for requirements management, work tracking, test management, traceability, and solution delivery.
• Experience using Microsoft Power BI for reporting, analytics, and operational insights.
• Experience using ServiceNow for incident, request, change, and knowledge management.
• Advanced proficiency with Microsoft 365 applications, including Teams, SharePoint, Excel, PowerPoint, Word, Power Apps, Power Automate, Power BI, and Copilot-enabled tools.
• Experience using artificial intelligence, automation, and agent-based solutions to streamline requirements gathering, design, testing, documentation, training, and other deliverable-creation activities.
• Experience working with external development partners on the delivery, testing, validation, and acceptance of software solutions.

#LI-GSK
Skills
Business Data Mining, Data Analysis, Data Analysis Tools, Data Mining, Data Modeling, Data Storytelling, SQL Databases, Statistical Analysis, Structured Query Language (SQL)
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 - usrecruitment.adjustments@gsk.com
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.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/