Senior MES Engineer

Please note, this role is not able to offer visa transfer or sponsorship now or in the future

We are seeking an experienced MES / GM  Lead to centrally develop a standardized set of Generic Master Batch Records (GMBRs) for global deployment. In this role, you will design batch 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.

• 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.

• Gather requirements and input from Process Owners, Automation teams, Process Development, and MES Platform representatives.
• Oversee the M  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.

• Define M  data requirements from ISA‑95 Level 2 automation interfaces, including line systems and analytical instruments; reduce or eliminate manual entries and verifications in E .
• Assess automation systems for data availability, identify gaps, and drive escalation and remediation with site automation/development teams.
• Develop integration touchpoint documentation for each M ; align with middleware/API development and testing needs.
• Support DCS integration and Instrument Data Acquisition (IDA) to interface analytical results into E .
• Enable data transfer using Characteristics (CX) values between MES orders and/or integrations with LIMS.

• Design and configure recipes in applicable platforms (e.g., Rockwell, SCADA, Delta
  
  V, 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.

• 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.

• Hands‑on experience with MES platforms such as Rockwell, SCADA, or Delta
  
  V.
• 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.

• 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.

• Experience qualifying electronic batch records and supporting validation activities within an electronic validation system.
• Strong documentation skills for integration standards, touchpoints, design guidelines,…