CQV Engineer - Commissioning & Qualification Expert

FITS LLC; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

FITS is seeking a CQV professional to support commissioning, qualification, and validation activities in field environments for our pharmaceutical, medical device, and manufacturing clients.

The role requires a Bachelor's degree in Science or Engineering with at least 2 years of CQV experience, fluency in Spanish and English, and the ability to generate protocols, report deviations, and coordinate resources to ensure compliant test execution.

Qualifications

• Bachelor's degree in Science or Engineering with at least 2 years of proven CQV experience.
• Bilingual Spanish and English fluency.
• Experience generating protocols and testing documents aligned with cGMP/FDA/ISPE standards.
• Ability to report deviations and participate in corrective actions with data integrity considerations.

Responsibilities

• Support commissioning, qualification and validation (CQV) activities in field settings.
• Support and influence to ensure CQV activities are completed on time according to the validation program.
• Participate in FAT/SAT for new equipment.
• Record results legibly and verifiably, following ALCOA principles where applicable.
• Report deviations, propose corrective actions, and verify corrections.
• Plan and coordinate resources, measurement/calibration equipment, and tooling for tests.
• Comply with site safety rules, permits, and policies while on site.

Skills

CQV experience

Bilingual Spanish/English

Education

Bachelor's degree in Science or Engineering

Job description

FITS is seeking a CQV professional to support commissioning, qualification, and validation activities in field environments for our pharmaceutical, medical device, and manufacturing clients.

The role requires a Bachelor's degree in Science or Engineering with at least 2 years of CQV experience, fluency in Spanish and English, and the ability to generate protocols, report deviations, and coordinate resources to ensure compliant test execution.