Senior Automation Engineer - Pharma Validation & Compliance

fitspr; Juncos (PR); On-site; USD 52,000 - 76,000; Full time

Job summary

fitspr is a service provider offering engineering, construction, maintenance, utilities and specialized technical services to pharmaceutical, medical device and manufacturing industries across the Island and the US.

The company seeks a validation-focused professional who can navigate regulatory standards, drive multi-department collaboration, and support FDA inspections while maintaining rigorous quality and compliance across complex systems.

Qualifications

• Bachelor's degree with two years of experience in pharma or regulated industry.
• Bilingual in English and Spanish.
• Experience with packaging equipment recipe entry and validation requirements.

Responsibilities

• Evaluate utility systems, process maintenance, instrumentation and cleaning systems for compliance with standards.
• Ensure maintenance team training and SOPs are consistent across the team.
• Coordinate technical support on engineering, regulatory, calibration, quality and environmental issues.
• Assist during FDA and other regulatory inspections with technical support.
• Support investigations of alert/action notifications for high purity water and environmental monitoring.
• Develop and maintain an audit program for the maintenance team and conduct routine audits.
• Assist engineering in evaluating improvements and optimization programs.
• Test proposed sanitization and maintenance procedure changes for processes and clean room systems.

Skills

Bilingual English/Spanish

Project Management

Regulatory knowledge

FDA compliance

Team collaboration

Education

Bachelor's Degree

Tools

Systech Systems

Validation protocols

Job description

fitspr is a service provider offering engineering, construction, maintenance, utilities and specialized technical services to pharmaceutical, medical device and manufacturing industries across the Island and the US.

The company seeks a validation-focused professional who can navigate regulatory standards, drive multi-department collaboration, and support FDA inspections while maintaining rigorous quality and compliance across complex systems.