Sr. Engineer 35958

Inteldot; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Inteldot in Puerto Rico seeks an Administrative Shift Engineer to drive process optimization and troubleshoot complex operations in manufacturing, pilot plants, or capital projects. The role applies advanced engineering principles to design and implement major system modifications and to present results for significant projects.

The ideal candidate brings experience in regulated pharma/biotech environments, ability to manage technical assessments, and a bilingual English/Spanish capability.

Qualifications

• Experience with manufacturing equipment in regulated pharma/biotech environments.
• Ability to independently manage technical assessments and equipment improvement initiatives.
• Experience in Medical Device or Pharma industries and bilingual (Eng/Span).

Responsibilities

• Perform system owner assessments related to equipment failures and quality events.
• Support technical investigations and develop corrective/preventive actions.
• Evaluate CAPA applicability and lessons for other areas.
• Manage Maximo work orders, reviews, approvals, and coordination.
• Develop/preventive maintenance strategies, job plans, SOPs.
• Implement engineering controls and close safety/INCA actions.
• Support troubleshooting, repairs, obsolescence replacements, spares studies.
• Work with biopharma equipment like centrifuges, autoclaves, tanks, chromatography.
• Prepare technical reports with clear rationales and traceable docs.
• Coordinate with Manufacturing, Process Eng., Maintenance, Quality, Automation, Validation, suppliers.
• Handle multiple assignments prioritizing safety, quality, and operations.

Skills

Manufacturing equipment experience

Regulated pharma/biotech experience

CAPA/ corrective actions

Bilingual English/Spanish

Education

Doctorate OR Masters + 2 years eng. exp. OR Bachelor's in engineering + 4 years eng. exp.

Job description

Inteldot

has over 15 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Administrative Shift

(8:00 AM - 5:00 PM)

Job Description

Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.

Requirements & Qualifications

• Experience supporting manufacturing equipment and systems in a regulated pharmaceutical or biotechnology environment.
• Ability to independently manage technical assessments, corrective actions, and equipment improvement initiatives.
• Experience in Medical Device or Pharma
• Bilingual (English/Spanish)

Responsibilities

• 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.

Education

• Doctorate OR Masters + 2 years of Engineering experience OR bachelor's in engineering + 4 years of Engineering experience.