Senior MES Engineer

Please note, this role is not able to offer visa transfer or sponsorship now or in the future Job Summary We are seeking an experienced MES / GMBR Lead to centrally develop a standardized set of Generic Master Batch Records (GMBRs) for global deployment. In this role, you will design batch records from the ground upu2014starting with compliance expectations, incorporating process direction and site-specific variation, and enabling MES functionality. You will partner closely with cross-functional stakeholders to reduce manual entries and exceptions, enable Review by Exception (RbE)/auto-closure, and establish integration standards between MES, automation systems, and laboratory platforms. Key Responsibilities GMBR / MBR Design & Delivery u00b7 Develop business process GMBRs, documentation, labeling requirements, design guidelines, and integration standards for global deployment. u00b7 Define unit operation inputs, outputs, and required process variations; ensure designs align to compliance expectations and execution needs. u00b7 Create parameterized MBRs based on site and process requirements to maximize reuse and standardization. u00b7 Enable productivity gains through Review by Exception (RbE) and auto-closure by designing records that minimize full-record review and approval routing. u00b7 Conduct design reviews and process-level health checks with site representatives and stakeholders. Stakeholder Collaboration & Governance u00b7 Gather requirements and input from Process Owners, Automation teams, Process Development, and MES Platform representatives. u00b7 Oversee the MBR approval workflow and secure approvals from Process Owners, Peer Authors, and Quality. u00b7 Maintain clear documentation, decision logs, and design rationale to support audits, training, and long-term sustainability. Automation & Integration Standards u00b7 Define MBR data requirements from ISA-95 Level 2 automation interfaces, including line systems and analytical instruments; reduce or eliminate manual entries and verifications in EBR. u00b7 Assess automation systems for data availability, identify gaps, and drive escalation and remediation with site automation/development teams. u00b7 Develop integration touchpoint documentation for each MBR; align with middleware/API development and testing needs. u00b7 Support DCS integration and Instrument Data Acquisition (IDA) to interface analytical results into EBR. u00b7 Enable data transfer using Characteristics (CX) values between MES orders and/or integrations with LIMS. Recipe Configuration, Execution & Validation u00b7 Design and configure recipes in applicable platforms (e.g., Rockwell, SCADA, DeltaV, FT Batch) to support automated execution. u00b7 Define and implement recipe parameters across mixed data types and hierarchical levels. u00b7 Generate and validate critical alarms/events during recipe execution to simulate real-world scenarios. u00b7 Extract and analyze data from EVT files and alarms/events databases using SQL queries. u00b7 Qualify GMBRs using electronic validation systems; support validation documentation and evidence collection. Continuous Improvement u00b7 Reduce exceptions by aligning record design to execution needs, simplifying record structures, and eliminating manual data entry where possible. u00b7 Establish and refine design standards and best practices to improve consistency across sites and products. Required Qualifications & Skills MES & Batch Record Expertise u00b7 Hands-on experience with MES platforms such as Rockwell, SCADA, or DeltaV. u00b7 Strong knowledge of ISA-95 standards and Level 2 automation interfaces. u00b7 Proven experience designing GMBRs/MBRs, including compliance-driven design, process variation, and RbE/auto-closure concepts. Automation, Integration & Data u00b7 Experience integrating MES with automation systems (DCS/SCADA) and enabling Instrument Data Acquisition (IDA). u00b7 Working knowledge of LIMS integrations and data transfer mechanisms (e.g., Characteristics/CX values). u00b7 Strong SQL skills to query EVT files and alarms/events databases; ability to reconcile and validate execution data. Validation & Compliance u00b7 Experience qualifying electronic batch records and supporting validation activities within an electronic validation system. u00b7 Strong documentation skills for integration standards, touchpoints, design guidelines, and data mapping. Soft Skills u00b7 Strong stakeholder management and ability to collaborate across Process Owners, Automation, Integration, and Quality teams. u00b7 Analytical, detail-oriented approach to problem solvingu2014especially around exception reduction and automation gap assessments. u00b7 Adaptability to evolving global requirements and the ability to coordinate multiple workstreams effectively. u00b7 Continuous improvement mindset focused on productivity gains, compliance enforcement, and automation optimization. Work Arrangement remote work model. Travel, if required, will be based on project needs and site engagement requirements. Compensation Salary range: $113,000 to 132,000. Compensation is based on experience, skills, and location, and may include performance-based incentives where applicable. Benefits u00b7 Medical, dental, and vision insurance u00b7 401(k) retirement plan with company participation u00b7 Paid time off (PTO) and paid holidays u00b7 Life and disability insurance u00b7 Employee assistance and wellness programs u00b7 Learning and professional development opportunitiesCognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Created: 2026-01-30