MES Change Management Specialist – Manufacturing / CSV Validation

Tranzeal is an industry leading global Business Transformation Service Provider offering specific consulting services as well as prepackaged, industry specific solutions and services to companies around the world. Our Consulting Services are dedicated to helping our clients maximize their investments in IT and the overall effectiveness and efficiency of the business. Tranzeal s deep industry experience makes us the partner of choice for a growing number of Fortune 1000 companies, midsize enterprises and small businesses worldwide.We are currently looking for 'MES Change Management Specialist – Manufacturing / CSV Validation' to support one of our clients with the following skills:Requirement:Job Title: MES Change Management Specialist – Manufacturing / CSV Validation

Location: Hillsboro, OR (Local Candidates Only – No Relocation)Duration: 8+ Months (Extendable Contract)Pay Rate: $65–$72/hr on W2 (All-Inclusive)Mandatory Skills:Manufacturing Environment Experience, Manufacturing Execution Systems (MES), Electronic Batch Records (EBR), Computer System Validation (CSV), Computer Software Assurance (CSA), GAMP, MES Change Management, Veeva, TrackWise, User Requirements Gathering, Test Script Development and Execution, Configuration Verification (CV), Functional Verification (FV), Validation Protocols, Test Plans and Reports, Deviation Management, Corrective and Preventive Actions (CAPA), SAP, Programmable Logic Controllers (PLC), Human-Machine Interface (HMI), Regulated Manufacturing, Quality Systems, Technical DocumentationJob DescriptionWe are seeking an experienced MES Change Management Specialist to support pharmaceutical manufacturing operations in a highly automated production and packaging environment.

The ideal candidate must have hands-on manufacturing experience, strong expertise in Manufacturing Execution Systems (MES), Computer System Validation (CSV), change management, and electronic batch records (EBR).Key ResponsibilitiesGather user requirements and assess MES modifications for manufacturing operations.Manage MES changes from initiation through testing, implementation, and closure using change management systems such as Veeva or TrackWise.Develop, author, and execute CSV test scripts, Configuration Verification (CV), and Functional Verification (FV) protocols for MES recipes and workflows.Translate operational requirements into MES recipe and workflow specifications and validation test protocols.Investigate testing exceptions, deviations, and MES defects, ensuring effective corrective and preventive actions.Develop test plans and reports for MES changes, including new recipe implementations.Collaborate with Manufacturing, Process & Compliance, IT/OT, Master Data, Quality, and other cross-functional teams.Support MES-related site initiatives, including capital projects, technology transfers, DS/DP changes, shutdown projects, and new product launches.Troubleshoot manufacturing automation issues and support Rockwell systems.Analyze system performance data to identify opportunities for process improvement, cost reduction, and operational efficiency.Provide MES audit support, system demonstrations, and assistance with regulatory finding closures.Mandatory QualificationsBachelor's degree in a relevant field with 3–5 years of MES, Electronic Batch Record (EBR), or computerized systems experience in regulated manufacturing, or a relevant master's degree.Hands-on experience working in a manufacturing environment, preferably pharmaceutical manufacturing.Experience with MES, electronic batch records, and computerized system construction, testing, and validation.Strong knowledge of CSV/CSA, GAMP principles, software validation, and regulatory compliance.Experience managing electronic change controls using Veeva, TrackWise, or similar change management systems, from initiation through closure.Experience developing and executing test scripts, validation protocols, and test plans.Knowledge of manufacturing automation systems, including SAP, MES, PLC, and HMI.Experience with quality systems, technical documentation, and cross-functional coordination.Preferred QualificationsExperience in sterile pharmaceutical manufacturing, including solution preparation, equipment preparation, vial filling, prefilled syringes (PFS), formulation, inspection, and packaging.Experience troubleshooting Rockwell automation systems, remotely or on-site.Previous involvement in MES or EBR deployment and implementation projects.Experience managing complex or multi-site MES deviations and corrective actions.Note: Candidates must already be available to work in Hillsboro, OR. Relocation is not available.Interested candidates please share your updated resumes with sureshs@tranzeal.com