Senior GMP Systems Functional Consultant

Weil Group, Inc; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Weil Group Inc. is seeking a highly experienced GMP specialist to assess and advise on manufacturing quality-system configurations across ERP/MES/LIMS/eQMS platforms.

The role requires deep platform knowledge, hands-on GMP experience, and the ability to trace records and validation evidence to inform quality decisions. The specialist will explain platform configurations, status rules, and workflows, connect system behavior to material traceability and quality outcomes, and support practical

Qualifications

• Hands-on experience with the specific platform and function assigned to the assessment.
• Proven GMP experience with ERP/MES/LIMS/eQMS workflows.
• Ability to trace system records, configurations and transactions and explain impact on the assessed process.
• Professional English for technical records, deliverables and stakeholder discussions.
• Availability for 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.

Responsibilities

• Explain and assess the relevant platform configuration, transactions, status rules and workflows.
• Connect system behavior and validation evidence with material traceability or Quality decisions.
• Support platform-specific findings and practical improvement dependencies.

Skills

GMP platform knowledge

System configuration tracing

Quality system validation

English proficiency

Education

Quality/Pharma education

Tools

ERP system

MES system

LIMS system

eQMS system

Job description

Weil Group Inc. is identifying specialists for potential assignments within a proposed pharmaceutical manufacturing quality-system assessment. This opportunity is subject to confirmed specialist scope, project award and client confirmation.

Provide deep functional expertise in the specific GMP platform and process assigned after the installed systems are confirmed.

What you will do

• - Explain and assess the relevant platform configuration, transactions, status rules and workflows.
• - Connect system behavior and validation evidence with material traceability or Quality decisions.
• - Support platform-specific findings and practical improvement dependencies.

Mandatory requirements

• - Hands-on experience in the specific platform and function assigned to the assessment.
• - Practical GMP experience with the relevant ERP, MES, LIMS or eQMS workflow.
• - Ability to trace system records, configuration and transactions and explain their impact on the assessed process.
• - 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.
• - Understand configuration, material or batch status rules, workflows and relevant validation documentation.
• - Work with platform owners and the integration and data-integrity specialists.
• - Relevant systems, engineering, pharmaceutical or quality education, or equivalent platform experience.

Desired qualifications

• - Experience in the version and deployment model actually installed at the site.
• - Comparable implementations and subsequent operational support.
• - Platform-specific training or credentials relevant to the assigned function.

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