Validation Engineer for Pharma & Medical Devices

fitspr; Puerto Rico; On-site; USD 50,000 - 80,000; Full time

Job summary

fitspr is seeking a qualified Validation Specialist to support Validation protocols in the Pharmaceutical and Medical Devices sectors. The role focuses on writing, executing, and maintaining validation documents to FDA-aligned standards.

You will develop processes, investigate deviations, and ensure thorough data entry into the quality system, collaborating with engineering and manufacturing teams to keep operations compliant and efficient in both the island and US markets.

Qualifications

• Bachelor's Degree in Engineering and exposure to validation quality activities within Pharmaceutical or Medical Devices industry.
• Bilingual in Spanish and English with good communication.
• Experience in SOP Development, Validation Documentation, GMP & GDP.

Responsibilities

• Write, execute and maintain on a timely basis Validation protocols.
• Ensure timely, thorough and complete execution of all protocols, meeting FDA requirements.
• Ensure that all new and existing protocols are effectively integrated into manufacturing processes.
• Ensure documentation is thorough, accurate and entered on a timely basis into the quality system.
• Ensures complete and thorough investigation of all product failures, batch failures and deviations associated with validation sampling and testing.
• Develops documentation of investigations and communicates findings to ensure chance of recurrence is significantly minimized and resolution satisfies validation requirements.
• Responsible for developing and implementing process strategies, optimizing current processes, and maintaining process documents.
• Support the day to day process operations.

Skills

Engineering degree

Bilingual Spanish/English

Validation quality activities

SOP Development

GMP & GDP

Documentation

Team collaboration

Education

Bachelor's Degree in Engineering

Job description

fitspr is seeking a qualified Validation Specialist to support Validation protocols in the Pharmaceutical and Medical Devices sectors. The role focuses on writing, executing, and maintaining validation documents to FDA-aligned standards.

You will develop processes, investigate deviations, and ensure thorough data entry into the quality system, collaborating with engineering and manufacturing teams to keep operations compliant and efficient in both the island and US markets.