Senior Engineer, Biopharma Equipment & CAPA

Integrated Services for Productivity & Validation, Inc; Juncos (PR); On-site; USD 90,000 - 130,000; Part time

Job summary

Integrated Services For Productivity & Validation, Inc is seeking a qualified engineer to support biopharma manufacturing equipment in a regulated environment. You will independently manage technical assessments, CAPA actions, and equipment improvement initiatives.

Responsibilities include system owner assessments, CAPA applicability, maintenance planning in IBM Maximo, and coordinating with Manufacturing, Quality, and suppliers to ensure safety, quality, and throughput.

Qualifications

• Experience in regulated pharma/biotech manufacturing environments.
• Experience performing system owner assessments and CAPA.
• Proficient in maintenance planning and SOP development.

Responsibilities

• Perform system owner and engineering impact assessments for equipment issues.
• Manage work orders and maintenance coordination in IBM Maximo.
• Develop preventive maintenance strategies, job plans, and SOPs.
• Support equipment troubleshooting and modernization projects.
• Coordinate with Manufacturing, Quality, Validation, and suppliers.

Skills

Pharma/biotech environment

CAPA concepts

Preventive maintenance

Root cause analysis

Documentation practices

Cross-functional coordination

Education

Doctorate

Master's degree

Bachelor's degree

Tools

IBM Maximo

Job description

Integrated Services For Productivity & Validation, Inc is seeking a qualified engineer to support biopharma manufacturing equipment in a regulated environment. You will independently manage technical assessments, CAPA actions, and equipment improvement initiatives.

Responsibilities include system owner assessments, CAPA applicability, maintenance planning in IBM Maximo, and coordinating with Manufacturing, Quality, and suppliers to ensure safety, quality, and throughput.