Validation Engineer - Packaging

FITS LLC; Añasco (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

FITS LLC in the United States (Puerto Rico, Añasco) is seeking a seasoned Validation Engineer to advance packaging validation for sterile and non-sterile medical device systems. You will collaborate with Quality, Regulatory, and Product Development to execute studies, collect data, and document conclusions.

The ideal candidate holds a Bachelor’s degree in Engineering, at least four years in validation activities, and bilingual Spanish/English.

Qualifications

• Bachelor’s degree in engineering with at least four years in validation activities.
• Bilingual in Spanish and English.
• Experience with packaging validation and testing for medical device packaging systems.
• Familiarity with FDA QSR, ISO 13485, ISO 9001, MDR/CMDR preferred.

Responsibilities

• Support packaging validation and testing activities.
• Assist senior engineers with studies, protocols, and data analysis.
• Coordinate with Quality, Regulatory Affairs, and Operations.
• Maintain and document technical records and change control.

Skills

Packaging validation

Engineering documentation

Statistical analysis

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor’s degree in Engineering

Job description

WHAT MAKES YOU A FIT:

• The Technical Part:

  • Bachelor’s Degree in Engineering and at least four (4) years of exposure to Validation Engineering activities within the Pharmaceutical or Medical Devices industry.
  • Bilingual (Spanish and English)
  • Shift: Administrative & according to business needs
  • Experience in:
    • Packaging validation and testing activities for sterile and non-sterile medical device packaging systems.
    • Engineering documentation, data collection, technical reports, protocols, specifications, and change records.
    • Manufacturing processes, engineering concepts, and problem‑solving methodologies.
    • FDA QSR, ISO 13485, ISO 9001, GMP environments, MDR, and CMDR requirements (preferred).
    • Validation activities, laboratory testing, statistical analysis, and risk assessments (preferred).
    • Medical device packaging systems, sterile barrier systems, and validation methodologies (preferred).

• The Personality Part:

  • We are looking for someone who treats everyone they meet like family, especially our resources, clients and team members. Being a customer service pro is one of many talents. This person is full of bright ideas, eager to innovate, and consistently delivers top‑quality results.

AS A PIECE OF FITS, YOU WILL:

(The day-to-day on the job)

• Support packaging validation and testing activities for sterile and non-sterile medical device packaging systems.
• Assist senior engineers in the execution of packaging studies, validation protocols, engineering evaluations, and testing activities.
• Collect, organize, analyze, and document testing data to support validation efforts and engineering decision‑making.
• Support engineering activities including setup, sample preparation, data collection, and documentation tasks.
• Prepare and maintain technical documentation such as protocols, reports, test summaries, specifications, and change records.
• Coordinate activities with cross‑functional teams including Quality, Operations, Regulatory Affairs, and Product Development.
• Support troubleshooting efforts related to packaging performance, manufacturing processes, or testing issues.
• Assist with risk assessments, continuous improvement initiatives, and process optimization projects.
• Ensure compliance with internal procedures and applicable regulatory requirements including FDA QSR, ISO 13485, ISO 9001, MDR, and CMDR.
• Maintain accurate project records and support the timely completion of assigned deliverables.
• Participate in packaging line trials, validation builds, and manufacturing support activities.
• Provide on-site support across different shifts and weekends as required by project and operational needs.
• Demonstrate initiative, accountability, flexibility, and willingness to learn new technical skills and regulatory requirements.