Senior MES Engineer - PasX

*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 up—starting 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

·       Develop business process GMBRs, documentation, labeling requirements, design guidelines, and integration standards for global deployment.

·       Define unit operation inputs, outputs, and required process variations; ensure designs align to compliance expectations and execution needs.

·       Create parameterized MBRs based on site and process requirements to maximize reuse and standardization.

·       Enable productivity gains through Review by Exception (RbE) and auto-closure by designing records that minimize full-record review and approval routing.

·       Conduct design reviews and process-level health checks with site representatives and stakeholders.

Stakeholder Collaboration & Governance

·       Gather requirements and input from Process Owners, Automation teams, Process Development, and MES Platform representatives.

·       Oversee the MBR approval workflow and secure approvals from Process Owners, Peer Authors, and Quality.

·       Maintain clear documentation, decision logs, and design rationale to support audits, training, and long-term sustainability.

Automation & Integration Standards

·       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.

·       Assess automation systems for data availability, identify gaps, and drive escalation and remediation with site automation/development teams.

·       Develop integration touchpoint documentation for each MBR; align with middleware/API development and testing needs.

·       Support DCS integration and Instrument Data Acquisition (IDA) to interface analytical results into EBR.

·       Enable data transfer using Characteristics (CX) values between MES orders and/or integrations with LIMS.

Recipe Configuration, Execution & Validation

·       Design and configure recipes in applicable platforms (e.g., Rockwell, SCADA, DeltaV, FT Batch) to support automated execution.

·       Define and implement recipe parameters across mixed data types and hierarchical levels.

·       Generate and validate critical alarms/events during recipe execution to simulate real-world scenarios.

·       Extract and analyze data from EVT files and alarms/events databases using SQL queries.

·       Qualify GMBRs using electronic validation systems; support validation documentation and evidence collection.

Continuous Improvement

·       Reduce exceptions by aligning record design to execution needs, simplifying record structures, and eliminating manual data entry where possible.

·       Establish and refine design standards and best practices to improve consistency across sites and products.

Required Qualifications & Skills

MES & Batch Record Expertise

·       Hands-on experience with MES platforms such as Rockwell, SCADA, or DeltaV.

·       Strong knowledge of ISA-95 standards and Level 2 automation interfaces.

·       Proven experience designing GMBRs/MBRs, including compliance-driven design, process variation, and RbE/auto-closure concepts.

Automation, Integration & Data

·       Experience integrating MES with automation systems (DCS/SCADA) and enabling Instrument Data Acquisition (IDA).

·       Working knowledge of LIMS integrations and data transfer mechanisms (e.g., Characteristics/CX values).

·       Strong SQL skills to query EVT files and alarms/events databases; ability to reconcile and validate execution data.

Validation & Compliance

·       Experience qualifying electronic batch records and supporting validation activities within an electronic validation system.

·       Strong documentation skills for integration standards, touchpoints, design guidelines, and data mapping.

Soft Skills

·       Strong stakeholder management and ability to collaborate across Process Owners, Automation, Integration, and Quality teams.

·       Analytical, detail-oriented approach to problem solving—especially around exception reduction and automation gap assessments.

·       Adaptability to evolving global requirements and the ability to coordinate multiple workstreams effectively.

·       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

·       Medical, dental, and vision insurance

·       401(k) retirement plan with company participation

·       Paid time off (PTO) and paid holidays

·       Life and disability insurance

·       Employee assistance and wellness programs

·       Learning and professional development opportunities