Engineer

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

For Validation services in the Engineering & Manufacturing areas.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's Degree in Engineering andprevious exposure to validation quality activities within the Pharmaceutical or Medical Devices industry.
• Bilingual, Spanish and English (good communication)
• Shift: Administrative & according to business needs
• Experience in:
  • SOP Development
  • Validation Documentation
  • GMP & GDP

The Personality Part:

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?

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

• 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.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent.We're FITS!

Are you the next piece?