Validation and Qualification Specialist

FITS, LLC; Guayama (PR); On-site; USD 60,000 - 80,000; Full time

Job summary

FITS, LLC in Guayama, Puerto Rico is seeking a qualified candidate to manage the qualification lifecycle in the manufacturing and engineering fields. You will develop and execute validation protocols, ensure compliance with GMP guidelines, and collaborate with various teams to enhance process quality.

The ideal candidate holds a Bachelor’s Degree in Life Sciences or Engineering and is bilingual in Spanish and English, bringing valuable experience to our family-oriented team. If you are innovative and dedicated to service excellence, we invite you to apply!

Qualifications

• Previous exposure to Validation and/or Qualification activities in pharmaceuticals.
• Experience with GMP & GDP regulations.
• Knowledge of validation principles and lifecycle management.

Responsibilities

• Execute and manage the qualification lifecycle for equipment and processes.
• Develop, review, and execute validation protocols and reports.
• Generate and maintain change control documentation.
• Perform troubleshooting for validation-related issues.
• Ensure compliance with GMP and regulatory requirements.
• Collaborate with manufacturing and quality teams.
• Maintain accurate documentation in line with SOPs.

Skills

Bilingual: Spanish and English

Customer service skills

Problem-solving

Ability to innovate

Education

Bachelor’s Degree in Life Sciences or Engineering

Job description

For Validation & Qualification services in the Manufacturing and Engineering area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s Degree in Life Sciences or Engineering and previous exposure to Validation and/or Qualification activities within the pharmaceutical and medical devices industry.
• Bilingual: Spanish and English
• Shift: Administrative & according to business needs
• Experience in:
  • Validation principles, protocols, and lifecycle management
  • Manufacturing and packaging equipment.
  • GMP & GDP regulations

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)

• Execute and manage the qualification lifecycle for equipment and processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Develop, review, and execute validation protocols and reports in accordance with GMP and company standards.
• Generate and maintain change control documentation for equipment and process modifications.
• Perform troubleshooting and root cause analysis for validation-related issues.
• Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements throughout all validation activities.
• Collaborate with manufacturing, packaging, and quality teams to support equipment qualification and process improvements.
• Maintain accurate and timely documentation in alignment with internal SOPs and regulatory expectations.

WHO WE ARE:

We are a Service Provider company different 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 industry clients with top-notch quality talent. We’re FITS!