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Senior MES MBR Author

$125k - $135k

Cognizant Technology Solutions

Senior MES MBR Author & Coordinator (PAS-X) About The Role As a Senior MES MBR Author & Coordinator , you will make an impact by designing, authoring, coordinating, and supporting electronic Master Batch Records (eMBRs) within the PAS-X Manufacturing Execution System (MES) environment. You will be a valued member of the Manufacturing Digitalization team and work collaboratively with Manufacturing, Process Engineering, MSAT, Quality Assurance, Validation/CSV, Automation, and IT stakeholders to ensure compliant, production-ready batch records that support GMP manufacturing operations. In this role, you will play a critical part in enabling right-first-time manufacturing by ensuring electronic batch records are accurate, compliant, and optimized for shop‑floor execution while supporting data integrity, operational excellence, and regulatory compliance. In This Role, You Will Author, configure, maintain, and enhance PAS‑X electronic Master Batch Records (eMBRs), master recipes, workflows, equipment phases, material consumption requirements, data collection forms, prompts, checks, and electronic signatures. Translate manufacturing processes, process descriptions, and operational instructions into scalable, compliant, and production‑ready PAS‑X solutions. Implement error-proofing mechanisms, conditional logic, dependencies, constraints, and system controls to improve compliance, reduce deviations, and support ALCOA+ data integrity principles. Maintain master data elements related to materials, BOMs, consumables, equipment, units, process parameters, and sample points required for batch execution. Coordinate cross‑functional review cycles and approvals with Manufacturing, Quality Assurance, MSAT, Validation/CSV, Automation, and IT teams. Manage master record versioning, traceability, controlled releases, and document lifecycle activities in alignment with site change control procedures. Ensure eMBR design, implementation, and maintenance comply with GMP requirements and site data integrity standards. Provide hands‑on manufacturing support, end‑user training, troubleshooting, and issue resolution related to PAS‑X master records, master data, workflow logic, and system execution. Support deviation investigations through execution trace reviews, recipe analysis, root cause identification, and corrective action recommendations. Support manufacturing campaigns, production start‑ups, recipe cutovers, and critical operations requiring shop‑floor presence. Work Model At Cognizant, we strive to provide flexibility wherever possible, and we are here to support a healthy work‑life balance through our various wellbeing programs. Based on this role's business requirements, this is an onsite position requiring 4 days per week in a client or Cognizant office in Atlanta, Georgia . The working arrangements for this role are accurate as of the date of posting. This may change based on the project you're engaged in, as well as business and client requirements. Rest assured; we will always be clear about role expectations. What You Need to Have to Be Considered Bachelor's degree in Engineering, Life Sciences, Computer Science, Information Technology, or a related field, or equivalent professional experience. Experience authoring, configuring, and maintaining electronic Master Batch Records (eMBRs) using Werum PAS‑X or comparable MES platforms. Strong understanding of pharmaceutical, biotech, or life sciences manufacturing processes within GMP‑regulated environments. Experience supporting MES recipe development, deployment, lifecycle management, and manufacturing execution. Knowledge of GxP regulations, ALCOA+ principles, electronic records, electronic signatures, and data integrity requirements. Experience managing change controls, document management, version control, and controlled release processes. Experience collaborating effectively with Manufacturing, Quality, Validation/CSV, Automation, MSAT, and IT stakeholders. Ability to troubleshoot MES execution issues, master data discrepancies, workflow logic failures, and user access challenges. Strong communication, organizational, analytical, and problem‑solving skills. These Will Help You Stand Out Hands‑on experience with PAS‑X recipe design, workflow modeling, equipment integration, and master data management. Experience supporting pharmaceutical, biotechnology, vaccine, cell therapy, gene therapy, or other regulated manufacturing operations. Knowledge of Computer System Validation (CSV), qualification, commissioning, and validation processes. Experience supporting manufacturing startup activities, production campaigns, and recipe migration or cutover activities. Familiarity with SAP, LIMS, historian systems, automation platforms, and MES integrations. Experience supporting deviation investigations, CAPA activities, and root cause analysis. Understanding of ISA‑95, GAMP 5, and digital manufacturing best practices. Industry certifications related to MES, PAS‑X, validation, or GMP operations. Salary And Other Compensation The annual salary for this position is anticipated to be between $125,000 and $135,000 , depending on experience, qualifications, geographic location, skills, and other job‑related factors. This position is also eligible for Cognizant's discretionary annual incentive program, based on performance and subject to the terms of Cognizant's applicable plans. Benefits Cognizant offers a comprehensive and competitive benefits package designed to support the health, wellbeing, and financial security of our associates and their families, including: Medical, dental, and vision insurance Health Savings Account (HSA) and Flexible Spending Accounts (FSA), where applicable Company‑paid life insurance and disability coverage 401(k) retirement savings plan with company contributions, subject to plan provisions Paid time off, company holidays, and leave programs Employee Assistance Program (EAP) Wellbeing and mental health resources Professional development, training, and certification opportunities Career growth and internal mobility programs Associate recognition and reward programs Benefits may vary by location and employment status and are subject to change. Application Deadline Applications will be accepted until September 30, 2026 . Cognizant reserves the right to close this posting earlier based on application volume, business needs, or hiring timelines. #J-18808-Ljbffr Cognizant

Vacancy posted 2 days ago
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