Pharma Manufacturing Systems Specialist (Validation)

fitspr; Juncos (PR); On-site; USD 60,000 - 85,000; Full time

Job summary

FITS is a service provider company delivering Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island and in the US. We pride ourselves on being flexible, family-oriented and focused on the well-being of our resources while providing top-quality talent to Pharmaceutical, Medical Device and Manufacturing clients.

Are you the next piece? We seek a validation-focused engineer who can navigate regulatory standards, manage cross-functional collaboration,

Qualifications

• Bachelor's degree with two years of experience as an engineer in pharma or regulated industry.
• Fluency in English and Spanish, with ability to communicate across teams.
• Experience with validation protocols and packaging equipment.
• Experience with regulatory and FDA standards.

Responsibilities

• Evaluate and maintain compliance for utility, process, instrumentation, calibration, and cleaning systems.
• Ensure training programs and SOPs are consistent across the maintenance team.
• Coordinate technical support on engineering, regulatory, calibration, quality, and environmental issues.
• Assist with FDA inspections and regulatory responses.
• Support high-purity water systems and environmental monitoring investigations.
• Develop and maintain an audit program for maintenance activities.
• Assist engineering in improvements and optimization programs.
• Test proposed sanitization and maintenance changes for process and clean room systems.

Skills

Project management

Bilingual (EN/ES)

Regulatory compliance

FDA standards

Validation

Recipe entry

Systech systems

Automation assessments

Pharma industry

Education

Bachelor's degree in Engineering

Tools

Systech Systems

MS Office

Job description

FITS is a service provider company delivering Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island and in the US. We pride ourselves on being flexible, family-oriented and focused on the well-being of our resources while providing top-quality talent to Pharmaceutical, Medical Device and Manufacturing clients.

Are you the next piece? We seek a validation-focused engineer who can navigate regulatory standards, manage cross-functional collaboration,