Pharma Validation Engineer – Sterile & Packaging

FITS LLC; Manatí (PR); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Work on high‑impact projects in Puerto

Grow across FITS’ network in pharma/bi

Job summary

FITS LLC in Puerto Rico is seeking an MS&T Engineer to support sterile validation and/or non-sterile packaging projects. You will work with cross-functional teams on qualification, validation, project execution, and documentation in a regulated pharmaceutical environment.

The ideal candidate holds a Bachelor’s degree in engineering and is bilingual in Spanish and English, with pharma manufacturing experience and knowledge of cGMP. Administrative shift; on-site in Manatí.

Qualifications

• Bachelor’s Degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, Industrial Engineering, Biomedical Engineering, or another related engineering/scientific discipline.
• Shift: Administrative and according to business needs
• Bilingual (Spanish and English)

Responsibilities

• Provide engineering and technical support to Manufacturing Science & Technology activities within a regulated pharmaceutical manufacturing environment.
• Support validation activities for sterile manufacturing processes, equipment, and systems, as applicable.
• Develop, review, and execute validation protocols, including IQ, OQ, PQ, and related technical documentation.
• Support packaging engineering projects for non-sterile manufacturing operations, including equipment upgrades, improvements, and new implementations.
• Coordinate project activities with Manufacturing, Engineering, Quality, Validation, Maintenance, and other cross‑functional teams.
• Assist with equipment qualification, commissioning, troubleshooting, and implementation activities.
• Evaluate manufacturing and packaging processes to identify opportunities for reliability, efficiency, and compliance improvements.
• Support investigations, deviations, change controls, CAPAs, and other quality system activities associated with assigned projects.
• Prepare and maintain technical documentation in compliance with current Good Manufacturing Practices (cGMP) and site procedures.
• Provide technical support during project execution, validation activities, manufacturing operations, and regulatory or internal inspection readiness.

Skills

Bilingual (Spanish/English)

Education

Bachelor’s degree in engineering or related field

Job description

FITS LLC in Puerto Rico is seeking an MS&T Engineer to support sterile validation and/or non-sterile packaging projects. You will work with cross-functional teams on qualification, validation, project execution, and documentation in a regulated pharmaceutical environment.

The ideal candidate holds a Bachelor’s degree in engineering and is bilingual in Spanish and English, with pharma manufacturing experience and knowledge of cGMP. Administrative shift; on-site in Manatí.