Sr Engineer - 35958

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 | Contract

Juncos, Puerto Rico | Posted on 11/12/2026

We provide the industry with a platform of solutions designed to their actual needs. We share and implement leading edge technology and methods that exceed customer expectation and deliver a one-stop provider of services focus on the well-being of the company and the employees.

Job Description

The ideal candidate will have experience supporting manufacturing equipment and systems in a regulated pharmaceutical or biotechnology environment, with the ability to independently manage technical assessments, corrective actions, and equipment improvement initiatives.

Performing System Owner assessments and engineering impact assessments related to equipment failures, process deviations, and quality events.

Supporting technical investigations, identifying equipment failure mechanisms, and developing corrective and preventive actions to reduce recurrence.

Evaluating the applicability of CAPA and lessons learned to other equipment, systems, and manufacturing areas.

Managing engineering activities in IBM Maximo, including work order technical review, pre-approval and post-approval activities, maintenance coordination, and follow-up through closure.

Developing and revising preventive maintenance strategies, Job Plans, inspection requirements, and SOPs.

Implementing engineering controls and completing actions associated with safety incidents and INCA records.

Supporting equipment troubleshooting, repair coordination, replacement of obsolete equipment, spare parts evaluations, and equipment modernization projects.

Working with biopharmaceutical manufacturing equipment such as centrifuges, autoclaves, process tanks, chromatography and UF/DF systems, homogenizers, filter integrity testers, and associated instrumentation.

Preparing clear technical reports and assessment rationales, maintaining traceable supporting documentation, and completing actions within established deadlines.

Coordinating with Manufacturing, Process Engineering, Maintenance, Quality, Automation, Validation, and equipment suppliers.

Managing multiple concurrent assignments and prioritizing work according to safety, quality, and operational needs..

Requirements

• Doctorate OR Masters + 2 years of Engineering experience OR
• -Bachelors in Engineering + 4 years of Engineering experience.