Manufacturing Engineering Lead - Pharma Process Innovator

FITS LLC; Añasco (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

FITS LLC in Puerto Rico seeks a Manufacturing Engineer to support the Base Business area. The role requires a Engineering degree and 4+ years in pharmaceutical or medical device manufacturing, with bilingual English/Spanish communication and ability to adapt shifts as needed.

Candidates should have hands-on experience with manufacturing systems and tools such as Agile, Cognex, Box, and SAP, plus strong Excel/Minitab skills for data analysis and reporting.

Qualifications

• Bachelor's Degree in Engineering and at least four (4) years of experience in Manufacturing within the Pharmaceutical or Medical Devices industry.
• Bilingual, Spanish and English (good communication).
• Shift: Administrative & according to business needs.
• Experience in manufacturing systems and digital tools such as Agile, Cognex, Box, SAP, and other engineering/business applications.
• Microsoft Excel, Minitab, and general statistical analysis, with the ability to prepare accurate reports, documentation, and support data-driven decisions.

Responsibilities

• Ensure that all new and existing protocols are integrated into manufacturing processes.
• Ensure documentation is thorough, accurate, and entered on a timely basis into the quality system.
• Ensure complete and thorough investigation of all product failures, batch failures, and deviations related to validation sampling and testing.
• Develop documentation of investigations and communicate findings to minimize recurrence and satisfy client requirements.
• Develop and implement process strategies, optimize current processes, and maintain process documents.
• Support day-to-day process operations.

Skills

Bilingual (Spanish/English)

Manufacturing systems

Agile

Cognex

Box

SAP

Excel

Minitab

Statistical analysis

Education

Bachelor's Degree in Engineering

Tools

SAP

Cognex

Box

Agile

Excel

Minitab

Job description

FITS LLC in Puerto Rico seeks a Manufacturing Engineer to support the Base Business area. The role requires a Engineering degree and 4+ years in pharmaceutical or medical device manufacturing, with bilingual English/Spanish communication and ability to adapt shifts as needed.

Candidates should have hands-on experience with manufacturing systems and tools such as Agile, Cognex, Box, and SAP, plus strong Excel/Minitab skills for data analysis and reporting.