Senior GMP Automation and Equipment Data Consultant

Weil Group, Inc; Manatí (PR); On-site; USD 120,000 - 160,000; Full time

Job summary

Weil Group, Inc. seeks a Senior GMP Automation and Equipment Data Consultant to assess automation and data controls within a pharmaceutical manufacturing quality system.

The role focuses on tracing equipment events to batch history and evaluating data for quality decisions, with recommendations to close gaps. The consultant will review control systems and historian data, ensure traceability across events, records and batches, and collaborate with stakeholders on practical remediation strategies.

Qualifications

• 7+ years of direct GMP automation or equipment-data experience.
• Ability to establish traceability between equipment, events, records and the applicable batch.
• Hands-on assessment of control-system or historian data for manufacturing or Quality review.
• Professional English for technical records, deliverables and stakeholder discussions.
• Availability for assigned on-site work in Manatí, PR, with approved remote work where appropriate.

Responsibilities

• Trace relevant equipment events and process data to the associated batch and record history.
• Review data timing, recipes, alarms, access and interfaces where relevant to Quality decisions.
• Recommend practical controls for identified automation-data or equipment-record gaps.

Skills

GMP automation experience

Traceability

Hands-on data assessment

Professional English

On-site availability

Confidentiality

Education

Automation/Electrical/Computer/Process Engineering education

Tools

Control systems (PLC/SCADA)

Data historians (e.g., PI)

MES interfaces

Job description

Senior GMP Automation and Equipment Data Consultant

• Manati, PR
• Biotech/Pharmaceutical

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.

Assess critical equipment and automation records and their relationship to manufacturing events, materials and batches.

What you will do

• Trace relevant equipment events and process data to the associated batch and record history.
• Review data timing, recipes, alarms, access and interfaces where relevant to Quality decisions.
• Recommend practical controls for identified automation-data or equipment-record gaps.

Mandatory requirements

• Practical GMP automation or equipment-data experience.
• Ability to establish traceability between equipment, events, records and the applicable batch.
• Hands-on assessment of relevant control-system or historian data and their use in manufacturing or Quality review.
• 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.
• Evaluate relevant timestamps, recipes, alarms, access and electronic record integrity.
• Understand equipment or automation validation documentation, change control and interfaces.
• Relevant automation, electrical, computer or process engineering education, or equivalent practical experience.

Desired qualifications

• Experience with the installed control systems, historians and interfaces.
• Complex equipment-to-MES or historian-to-batch integrations.
• Implemented improvements in GMP automation-data controls or review practices.

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