Senior Autoclave and Utility Qualification Specialist

Veg Group; Aguadilla (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks an Autoclave and Supporting Utility Qualification Specialist to lead qualification of autoclave systems and water/clean steam networks in San Juan and Aguadilla.

You will develop IQ/OQ/validation documents, execute tests, and ensure traceability from requirements to acceptance, while coordinating field activities on site. Ideal candidates have a Bachelor's in Engineering and hands-on CSV/GxP experience, strong English

Qualifications

• Bachelor's degree in Engineering or related field.
• Experience developing and executing qualification protocols and CSV lifecycle documents.
• Experience supporting qualification or CSV work in pharmaceutical, biologics, or comparable GxP environments.
• Working knowledge of GMP, GDP, regulatory guidance, data integrity, risk-based qualification and validation, FDA cGMP requirements, and ISPE/GAMP principles.
• Strong written and verbal communication skills in English; Spanish proficiency preferred.

Responsibilities

• Review facility, design, commissioning, vendor, maintenance, calibration, operating, and prior qualification documentation; document gaps and readiness constraints.
• Develop or revise IQ/OQ protocols and related lifecycle documents.
• Define and execute qualification strategy including installation verification, utility verification, and testing.
• Verify qualification of water and Clean Steam Generation systems within scope.
• Coordinate field activities, sampling, and instrument calibration for on-site execution.
• Assemble executed protocols and evidence into a complete package for review and closure.

Skills

Communication skills

English proficiency

Regulatory knowledge

Documentation writing

Education

Bachelor's degree in Engineering or related field

Job description

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks an Autoclave and Supporting Utility Qualification Specialist to lead qualification of autoclave systems and water/clean steam networks in San Juan and Aguadilla.

You will develop IQ/OQ/validation documents, execute tests, and ensure traceability from requirements to acceptance, while coordinating field activities on site. Ideal candidates have a Bachelor's in Engineering and hands-on CSV/GxP experience, strong English