Senior Automation Engineer - Pharma Compliance & Innovation

FITS LLC; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

FITS LLC in Puerto Rico is seeking an engineer with a Bachelor's degree and two years of experience in the pharmaceutical or regulated industry. The role requires bilingual English and Spanish, and experience with packaging equipment, validation protocols, and Systech Systems.

You will collaborate across maintenance and engineering, ensuring compliance with industry and FDA standards, supporting inspections, audits, and continuous improvement efforts, and helping to maintain training programs

Qualifications

• Bachelor's degree with two years of experience as an Engineer in pharma or regulated industry.
• Bilingual English & Spanish.
• Project Management skills.
• Shift: Administrative and according to business needs.
• Experience in: Recipe entry in packaging equipment.
• Validation protocol requirements.
• Parameter and Systech Systems.
• Automation assessments.

Responsibilities

• Evaluate and determine if utility systems, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards.
• Ensure the maintenance team training program, standard operating procedures and equipment/system operational standards are consistent throughout the team.
• Participate in the coordination of technical support to the maintenance team on engineering issues, regulatory issues, compliance issues, calibration issues, quality issues, microbial/environmental issues, technical cleaning issues, validation issues, electrical issues and process maintenance issues.
• Assist the maintenance team during FDA and other regulatory agency inspections. Provide technical support to the maintenance team in response to the FDA and other regulatory agencies.
• Assist the maintenance team when responding to high purity water systems and environmental monitoring alert/action notifications. Assist with the investigation on all alert/action notifications.
• Assist with the development and maintenance of an audit program for the maintenance team and facilitate routine audits of activities, documentation, operations and related areas to ensure a continued state of compliance.
• Assist plant engineering in the evaluation and implementation of engineering improvements, policy changes, compliance improvements and optimization programs.
• Assist with the testing of proposed sanitization and maintenance procedure changes and modifications for process, utility and clean room systems.

Skills

Bachelor's degree

Two years experience as engineer

Bilingual English Spanish

Project management

Shift: administrative

Recipe entry in packaging equipment

Validation protocol requirements

Systech Systems

Automation assessments

Education

Bachelor's degree

Tools

Systech Systems

Job description

FITS LLC in Puerto Rico is seeking an engineer with a Bachelor's degree and two years of experience in the pharmaceutical or regulated industry. The role requires bilingual English and Spanish, and experience with packaging equipment, validation protocols, and Systech Systems.

You will collaborate across maintenance and engineering, ensuring compliance with industry and FDA standards, supporting inspections, audits, and continuous improvement efforts, and helping to maintain training programs