Senior Process Engineer, Biopharma & CAPA Expert

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 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.