Senior GMP Systems Integration and Manufacturing Data Architect

Weil Group, Inc; United States; Hybrid; USD 100,000 - 150,000; Full time

Job summary

Weil Group Inc. is seeking qualified consultants for a pharmaceutical manufacturing quality-system assessment on a project basis, subject to award and client confirmation.

Assess how lot identifiers, quantities, status and data meaning are preserved across GMP systems and how failed or inconsistent hand-offs are detected and reconciled. This engagement requires on-site work in Manat, Puerto Rico, with approved remote work where appropriate.

Qualifications

• Experience assessing or integrating data flows between GMP manufacturing, materials, laboratory or quality systems.
• Ability to trace a real transaction through at least two critical systems and verify identifiers, quantities, units, status and timing.
• Hands-on analysis of failed messages, duplicates, retries, timing differences, reconciliation and exception controls.
• Connect interface failures with materials genealogy or release evidence and assess controls and validation documentation.
• Work directly with system owners, IT, automation and operations stakeholders.
• Professional English for technical records, deliverables and stakeholder discussions.
• On-site work in Manat, Puerto Rico with approved remote work where appropriate.
• Confidentiality, site and information-handling requirements.

Responsibilities

• Map actual interfaces between manufacturing, materials, laboratory and quality systems.
• Follow transactions across sources and receiving systems, including manual bridges and exceptions.
• Recommend feasible reconciliation, monitoring and error-handling controls that support genealogy and release.

Skills

Data integration

GMP systems

System interfaces

Stakeholder collaboration

Education

Engineering degree or equivalent

Tools

ERP/MRP

MES

LIMS

eQMS

Job description

Weil Group Inc. is identifying qualified consultants for a proposed pharmaceutical manufacturing quality-system assessment. This project-based opportunity is subject to project award and client confirmation.

Assess how lot identifiers, quantities, status and data meaning are preserved across GMP systems and how failed or inconsistent hand-offs are detected and reconciled.

What you will do

• Map actual interfaces between manufacturing, materials, laboratory and quality systems.
• Follow transactions across sources and receiving systems, including manual bridges and exceptions.
• Recommend feasible reconciliation, monitoring and error-handling controls that support genealogy and release.

Mandatory requirements

• Verifiable experience assessing or integrating data flows between GMP manufacturing, materials, laboratory or quality systems.
• Ability to trace a real transaction through at least two critical systems and verify identifiers, quantities, units, status and timing.
• Hands-on analysis of failed messages, duplicates, retries, timing differences, reconciliation and exception controls.
• Ability to connect interface failures with materials genealogy or release evidence and assess controls and validation documentation.
• Ability to work directly with system owners, IT, automation and operations stakeholders.
• Professional English for technical records, deliverables and stakeholder discussions.
• Availability for assigned on-site work in Manat, Puerto Rico, with approved remote work where appropriate.
• Ability to meet confidentiality, site and information-handling requirements and disclose potential conflicts affecting independent assessment.

Necessary qualifications

• Typically 7 or more years of directly relevant professional experience, or a demonstrably equivalent track record.
• Functional understanding of ERP/MRP, MES, LIMS, eQMS and warehouse systems; interpret maps, configurations and transaction logs.
• Reproducible analysis of approved data extracts or queries, and design of reconciliation and monitoring controls.
• Relevant education in engineering, information systems, automation or equivalent regulated-systems experience.

Desired qualifications

• Hands-on experience with the platforms, versions and interfaces confirmed for the project.
• Knowledge of automation, historians and equipment-to-batch data relationships.
• Complex genealogy, controlled migrations or multi-platform reconciliation projects.

**Weil Group is proud to be an Equal Employment Opportunity Employer.**