MES Change Specialist - BioPharma
BEPC Inc. - Business Excellence Professional Consulting · Hillsboro, OR
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Medical, Dental, Vision, and Life InsuranceNote: This is a W2 only role — C2C and C2H will not be considered.Role OverviewBEPC is seeking an experienced MES Change Specialist to support our customer's pharmaceutical manufacturing operations in Hillsboro, OR. This position will play a critical role in maintaining, optimizing, and validating Manufacturing Execution Systems (MES), Electronic Batch Records (EBR), and electronic manufacturing workflows within a highly automated, regulated pharmaceutical production and packaging facility.The successful candidate will collaborate with Manufacturing, Process and Compliance, IT/OT, Master Data, Quality, and Validation teams to ensure electronic manufacturing documentation and systems operate efficiently, accurately, and in compliance with regulatory requirements.This role combines MES change management, Computer System Validation (CSV), system troubleshooting, recipe and workflow configuration, and cross-functional project execution.The ideal candidate brings 3–5 years of relevant experience with a Bachelor's degree, or a relevant Master's degree, along with strong knowledge of regulated manufacturing systems, electronic change controls, and pharmaceutical manufacturing processes.Key ResponsibilitiesMES Change Management & System OptimizationLead and manage MES changes for assigned pharmaceutical manufacturing processes, from initiation through testing, implementation, and closure.Gather user requirements and evaluate operational needs for MES modifications and system improvements.Translate manufacturing requirements into MES recipe, workflow, and electronic documentation requirements.Collaborate with Manufacturing, IT/OT, Master Data, Quality, and other departments to coordinate MES changes.Manage electronic change controls through systems such as Veeva or TrackWise.Coordinate cross-functional action items to ensure changes are implemented accurately and on schedule.Monitor project timelines, identify potential delays, and escalate concerns to leadership.Analyze system performance data to identify opportunities to improve efficiency, reduce costs, and optimize manufacturing operations.Troubleshoot MES, automation, and production-related system issues to identify and implement effective resolutions.Computer System Validation & TestingOwn Computer System Validation (CSV) activities, including requirements definition, test script development, and test execution.Develop and execute test protocols for MES recipes, workflows, and computerized manufacturing systems.Author and execute Configuration Verification (CV) and Functional Verification (FV) protocols in accordance with approved procedures and CSV principles.Translate operational requirements into testable specifications and validation protocols.Prepare comprehensive test plans and reports for new or modified MES recipes and workflows.Investigate exceptions and deviations identified during CV and FV testing.Ensure validation activities support electronic data integrity, system functionality, and regulatory compliance.Maintain accurate validation documentation, testing records, and change control evidence.Deviations, Compliance & Regulatory SupportOwn and investigate MES-related deviations, including complex or multi-site issues associated with system defects.Identify root causes, coordinate corrective actions, and verify the effectiveness of implemented solutions.Support compliance with applicable cGMP, CSV/CSA, GAMP, and computerized system requirements.Maintain appropriate documentation to support regulatory inspections and internal audits.Serve as an MES subject matter resource during audits by providing system demonstrations, presentations, and technical explanations.Support the resolution and closure of MES-related regulatory findings when applicable.Collaborate with Quality and Compliance teams to ensure electronic manufacturing systems remain in a validated state.Manufacturing & Project SupportSupport MES activities associated with capital projects, technology transfers, Drug Substance/Drug Product (DS/DP) changes, facility shutdowns, and new product launches.Partner with manufacturing teams to ensure electronic recipes and workflows accurately support production operations.Provide technical support for highly automated pharmaceutical manufacturing and packaging processes.Collaborate with automation and engineering teams to troubleshoot issues involving MES, SAP, PLCs, HMIs, and related manufacturing systems.Support ongoing improvements to manufacturing documentation, system reliability, and operational performance.Required QualificationsBachelor's degree in a relevant field with 3–5 years of experience in MES, Electronic Batch Records, or computerized systems within regulated manufacturing; or a Master's degree in a relevant field.Experience with Manufacturing Execution Systems (MES), Electronic Batch Records (EBR), or computerized manufacturing systems.Prior experience with the construction, testing, and validation of computerized systems.Strong experience with electronic change management systems, such as Veeva, TrackWise, or comparable platforms.Demonstrated ability to manage change controls from initiation through implementation and closure.Experience coordinating change management activities across multiple departments.Knowledge of Computer System Validation (CSV), Computer Software Assurance (CSA), and GAMP principles.Experience developing requirements, writing test scripts, and executing validation protocols.Understanding of electronic data system testing requirements for regulatory compliance.Knowledge of manufacturing automation technologies, including SAP, MES, Programmable Logic Controllers (PLCs), and Human Machine Interfaces (HMIs).Experience with sterile pharmaceutical manufacturing processes, such as solution preparation, equipment preparation, vial filling, prefilled syringes, formulation, inspection, or packaging.Strong troubleshooting, analytical, and problem-solving skills.Ability to investigate deviations, evaluate system issues, and coordinate corrective actions.Strong technical documentation and communication skills.Ability to collaborate effectively with Manufacturing, IT/OT, Quality, Validation, and cross-functional stakeholders.Preferred QualificationsPrevious experience supporting MES or EBR deployment projects.Hands-on experience troubleshooting Rockwell automation systems, including remote or onsite technical support.Background in IT, Operational Technology (OT), software technical writing, quality systems, or computerized system validation.Experience supporting MES changes during pharmaceutical technology transfers, facility expansions, or new product launches.Experience with complex MES deviations or multi-site manufacturing system issues.Manufacturing & Work EnvironmentThis position supports a highly automated pharmaceutical manufacturing and packaging facility operating under strict regulatory and quality requirements.Candidates should be comfortable with:Supporting MES and electronic manufacturing systems in a regulated production environment.Working closely with manufacturing, engineering, automation, IT/OT, quality, and validation teams.Troubleshooting computerized systems and automation-related production issues.Managing multiple change controls, validation activities, and project deliverables simultaneously.Following applicable cGMP, data integrity, change management, and validation procedures.Supporting manufacturing initiatives that require coordination across multiple departments.About BEPCBEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.Apply Now!