Validation Engineer: Lean GMP & Process Excellence

FITS LLC; Añasco (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

FITS LLC in Puerto Rico seeks a Validation Engineer to support engineering validations in the Pharmaceutical or Medical Device sector. The role requires an Engineering degree and hands-on validation, Lean manufacturing, and GMP/GDP experience.

You will write and execute validation protocols, ensure FDA-aligned documentation, and contribute to process improvements while collaborating with a tight-knit team. Bilingual English/Spanish communication is essential, and the shift is administrative,

Qualifications

• Bachelor’s degree in Engineering with 3+ years in Validation/Lean Manufacturing in pharma/medical devices.
• Shift is administrative and varies with business needs.
• Experience with Validation Protocols.
• Experience with Lean Manufacturing.
• Knowledge of GMP & GDP regulations.

Responsibilities

• Write, execute, and maintain validation protocols.
• Ensure timely, thorough execution of all protocols meeting FDA requirements.
• Integrate new/existing protocols into manufacturing processes.
• Ensure documentation is thorough and entered on time into the quality system.
• Investigate product/batch deviations and validation sampling issues.
• Document investigations and communicate findings to minimize recurrence.
• Develop and implement process strategies and maintain process documents.
• Support day-to-day process operations.

Skills

Validation Protocols

Lean Manufacturing

GMP/GDP regulations

Verbal communication

Written communication

Bilingual English/Spanish

Education

Bachelor's degree in Engineering

Job description

FITS LLC in Puerto Rico seeks a Validation Engineer to support engineering validations in the Pharmaceutical or Medical Device sector. The role requires an Engineering degree and hands-on validation, Lean manufacturing, and GMP/GDP experience.

You will write and execute validation protocols, ensure FDA-aligned documentation, and contribute to process improvements while collaborating with a tight-knit team. Bilingual English/Spanish communication is essential, and the shift is administrative,