Senior GMP Systems Integration and Manufacturing Data Architect

Weil Group, Inc; Manatí (PR); Hybride; USD 120 000 - 160 000; Plein temps

Résumé du poste

Weil Group Inc. in Manatí, Puerto Rico, seeks a Senior GMP Systems Integration and Manufacturing Data Architect to assess how lot identifiers, quantities, status and data meaning are preserved across GMP systems during manufacturing.

You will map interfaces between manufacturing, materials, laboratory and quality systems, trace transactions end-to-end, and propose reconciliation, monitoring and error-handling controls to support genealogy and release.

Qualifications

• 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 on-site work in Manatí, Puerto Rico, with approved remote work where appropriate.
• Ability to meet confidentiality, site and information-handling requirements and disclose potential conflicts affecting independent assessment.

Responsabilités

• 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.

Connaissances

GMP data integration

Data reconciliation controls

Systems interface mapping

Stakeholder communication

Analytical problem solving

Documentation & audit trails

Formation

Engineering or information systems degree

Outils

ERP/MRP systems

MES

LIMS

eQMS

Warehouse systems

Description du poste

Senior GMP Systems Integration and Manufacturing Data Architect

• Manati, PR
• Biotech/Pharmaceutical

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 Manatí, 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.