Validation & Qualification Specialist - GMP & IQ/OQ/PQ

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

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!