CQV Engineer: Commissioning & Qualification Pro

FITS LLC; Juncos (PR); On-site; USD 80,000 - 120,000; Full time

Job summary

FITS LLC in Puerto Rico seeks a CQV specialist to support commissioning, qualification, and validation activities across pharma, medical device, and manufacturing sectors. The role requires a science/engineering degree and hands-on CQV field experience.

You will generate protocols, document deviations, coordinate resources, and ensure data integrity while complying with cGMP, FDA, and ISPE/ASTM E2500 standards. Bilingual Spanish-English is a plus.

Qualifications

• Bachelor’s Degree in Science or Engineering with at least 2 years of proven CQV experience.
• Bilingual Spanish and English.
• Experience in commissioning and qualification activities in the field.
• Generate protocols and technical documents aligned with cGMP, FDA, ISPE/ASTM E2500.
• Report deviations, propose corrective actions, and verify corrections.
• Plan and coordinate resources and equipment for tests.

Responsibilities

• Support the planning and execution of commissioning, qualification, and validation activities.
• Develop qualification protocols.
• Ensure CQV activities are completed on time and per the validation program.
• Develop validation status reports.
• Participate in FAT and SAT of new equipment.
• Record results with data integrity (ALCOA).
• Report deviations and assist in corrective actions.
• Plan and coordinate resources and tooling for tests.
• Comply with site safety rules and policies.

Skills

Bilingual Spanish-English

CQV field experience

Protocol generation

Resource planning

Education

Bachelor's Degree in Science or Engineering

Tools

Measurement/Calibration equipment

Testing equipment

Job description

FITS LLC in Puerto Rico seeks a CQV specialist to support commissioning, qualification, and validation activities across pharma, medical device, and manufacturing sectors. The role requires a science/engineering degree and hands-on CQV field experience.

You will generate protocols, document deviations, coordinate resources, and ensure data integrity while complying with cGMP, FDA, and ISPE/ASTM E2500 standards. Bilingual Spanish-English is a plus.