Pharma Automation Engineer - Compliance & Validation Lead

FITS, LLC; Juncos (PR); On-site; USD 55,000 - 75,000; Full time

Job summary

FITS, LLC in Juncos, Puerto Rico, is seeking an engineer with a Bachelor's degree and 2+ years in the pharmaceutical or regulated industry to support maintenance across departments. The role emphasizes compliance with FDA standards and coordination with utility, process, and instrumentation systems.

The position includes involvement in inspections, auditing, and continuous improvement of engineering practices, while assisting with validation, cleaning, and environmental monitoring activities as

Qualifications

• Bachelor's degree with two years of experience in pharmaceutical or regulated industry.
• Experience with packaging equipment recipe entry, validation protocols, and systems (Systech).
• Willingness to work in an administrative shift and collaborate across departments.

Responsibilities

• Evaluate utility systems, process maintenance, instrumentation, calibration, electrical, and cleaning systems for compliance.
• Ensure maintenance training programs, SOPs and equipment standards are consistent across teams.
• Coordinate technical support for engineering, regulatory, compliance, calibration, quality and environmental issues.
• Assist during FDA and other regulatory inspections with technical support.
• Assist with high purity water systems and environmental monitoring alerts and investigations.
• Help develop and maintain an audit program for maintenance activities and documentation.
• Assist plant engineering with engineering improvements and optimization programs.
• Assist testing of proposed sanitization and maintenance procedure changes for processes and clean rooms.

Skills

Recipe entry

Validation protocols

Parameter and Systech Systems

Automation assessments

Education

Bachelor's Degree with two years experience as Engineer

Job description

FITS, LLC in Juncos, Puerto Rico, is seeking an engineer with a Bachelor's degree and 2+ years in the pharmaceutical or regulated industry to support maintenance across departments. The role emphasizes compliance with FDA standards and coordination with utility, process, and instrumentation systems.

The position includes involvement in inspections, auditing, and continuous improvement of engineering practices, while assisting with validation, cleaning, and environmental monitoring activities as