Quality Validation Engineer II - IQ/OQ/PQ, DOE

Quality Consulting Group, LLC; Ponce (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

QUALITY CONSULTING GROUP, LLC in Puerto Rico and the US is seeking a Contingent Engineer II to support validation, qualification, and process improvement in a regulated manufacturing environment.

You will execute IQ/OQ/PQ protocols, perform DOE studies with Minitab, and prepare technical documentation while collaborating with cross-functional teams to ensure compliance with quality systems and regulatory requirements.

Qualifications

• Bachelor’s degree in engineering.
• 2–3 years of relevant experience in engineering, validation, quality, manufacturing, or a related technical field.
• Experience in a regulated manufacturing environment (medical device, pharmaceutical, or biotechnology).
• Experience with IQ/OQ/PQ protocol development and execution.
• Knowledge of process characterization and DOE methodologies.
• Experience with TMV and IMV.
• Proficiency in Minitab for statistics and data analysis.
• MS Office proficiency (Excel, Word, PowerPoint).
• Fully bilingual in English and Spanish (written and spoken).
• First Shift

Responsibilities

• Execute validation and qualification activities for equipment, processes, test methods, and manufacturing systems.
• Develop, review, and execute validation protocols (IQ/OQ/PQ) and related studies.
• Prepare, review, and maintain validation documentation and reports.
• Utilize Minitab for statistical analyses and DOE evaluations.
• Support investigations, CAPAs, and process improvement initiatives.

Skills

Bilingual English/Spanish

Strong written and verbal commun.,

Documentation quality

Education

Bachelor's Degree in Engineering

Tools

Minitab

Microsoft Office

Microsoft Project

Job description

QUALITY CONSULTING GROUP, LLC in Puerto Rico and the US is seeking a Contingent Engineer II to support validation, qualification, and process improvement in a regulated manufacturing environment.

You will execute IQ/OQ/PQ protocols, perform DOE studies with Minitab, and prepare technical documentation while collaborating with cross-functional teams to ensure compliance with quality systems and regulatory requirements.