Senior Biotech Equipment Engineer - GMP & CAPA Lead

Weil Group, Inc; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Weil Group, Inc. is seeking an experienced engineering professional to support manufacturing equipment in a regulated pharma/biotech environment.

You will independently manage technical assessments, investigations, and CAPA actions to improve equipment reliability and process efficiency. Responsibilities include coordinating with Manufacturing, Quality, and Validation teams, managing Maximo work orders, and developing preventive maintenance strategies and SOPs.

Qualifications

• Experience supporting manufacturing equipment in a regulated pharma/biotech setting.
• Ability to independently manage technical assessments, CAPA and equipment improvement actions.
• Familiarity with validation activities and documentation in a highly regulated environment.
• Experience with interpreting GLPs and GMPs and applying them to equipment
• Proven ability to coordinate with Manufacturing, Quality, Automation, Validation, and suppliers.

Responsibilities

• Perform System Owner assessments and engineering impact assessments related to equipment failures and quality events.
• Support technical investigations, identify failure mechanisms, and develop corrective actions to reduce recurrence.
• Evaluate CAPA applicability to other equipment and areas.
• Manage engineering activities in IBM Maximo including work order reviews and maintenance coordination.
• Develop and revise preventive maintenance strategies, Job Plans, and SOPs.
• Coordinate with internal teams and suppliers to drive equipment modernization projects.
• Prepare clear technical reports with traceable documentation and deadlines.
• Assist with troubleshooting, repairs, and obsolescence replacement of equipment.

Skills

Pharma/biotech processes

Validation processes

Documentation in regulated environment

GLPs and GMPs knowledge

Engineering problem solving

Interdisciplinary collaboration

Education

Master’s degree in Engineering

Bachelor’s degree in Engineering

Tools

IBM Maximo

Job description

Weil Group, Inc. is seeking an experienced engineering professional to support manufacturing equipment in a regulated pharma/biotech environment.

You will independently manage technical assessments, investigations, and CAPA actions to improve equipment reliability and process efficiency. Responsibilities include coordinating with Manufacturing, Quality, and Validation teams, managing Maximo work orders, and developing preventive maintenance strategies and SOPs.