Validation Engineer/Specialist

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

For MS&T Engineering services in the Manufacturing area.

FITS is looking for an MS&T Engineer to support a leading pharmaceutical manufacturer. You’ll support Sterile Validation and/or Non-Sterile Packaging projects, working with cross‑functional teams on equipment qualification, validation, project execution, and technical documentation. If you have hands‑on experience in pharmaceutical manufacturing and enjoy supporting technical projects from planning through execution, this role is for you.

WHAT MAKES YOU A FIT:

• 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)

Preferred Qualifications:

• Experience in the pharmaceutical, biotechnology, medical device, or other regulated manufacturing industry.
• Experience in sterile process/equipment validation and/or packaging equipment and engineering projects, depending on the assigned area.
• Working knowledge of cGMP requirements, validation principles, change control, deviations, CAPA, and technical documentation.

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Provide engineering and technical support to Manufacturing Science & Technology (MS&T) 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.

Being a FITS Piece Comes With Perks

• Work on high‑impact projects with one of Puerto Rico’s top pharmaceutical manufacturers
• Opportunities to grow your career across FITS’ network of clients in pharma, biotech, and medical devices

Who We Are

FITS is a Puerto Rico-based engineering and technical firm. We connect skilled professionals with leading companies in regulated industries, including pharmaceutical, biotech, medical device, and manufacturing. We believe the right talent fits like the right piece, and we work to make every placement a lasting match.

Are you the Next Piece?