Senior MES MBR Author
Listed on 2026-08-30
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Quality Assurance - QA/QC
Production QC/QA, Regulatory Compliance Specialist
Senior MES M Author & Coordinator (PAS-X) About the Role
As a Senior MES M 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 eM 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.
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
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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.
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