QA Validation Engineer II: Drive Quality & Compliance

Validation & Engineering Group; Carolina (PR); On-site; USD 70,000 - 95,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a QA Validation Analyst/Engineer II to plan and approve validation tasks across manufacturing processes, equipment, and information systems.

Under the Validation Section Manager, you will perform validation activities and contribute to quality program deployment at the plant. The role requires experience in validation investigations, SOP review, CAPA integration, and supporting regulatory audits.

Qualifications

• Bachelor's degree in Biology, Chemistry or Engineering.
• 2+ years of experience in Manufacturing, Quality or Engineering.
• Fully bilingual English/Spanish with excellent oral skills.

Responsibilities

• Participate in implementation and maintenance of the Quality System to meet regulatory requirements.
• Ensure practices and procedures comply with policies and regulations for Quality areas.
• Execute tasks to implement the Validation Master Plan and maintain validated state of equipment, utilities, facilities, and processes.
• Ensure investigations of validation failures are thorough and documented in the CAPA system when required.
• Collaborate with plant and external resources on new installations/systems to ensure cGMP compliance.
• May supervise contract validation resources.

Skills

Kaye Validator

TempTales

Temperature/RH mapping

Equipment/Utilities Validation

CIP/SIP Validation

Education

Bachelor's degree in Biology, Chemistry or Engineering

Job description

Validation & Engineering Group, Inc. seeks a QA Validation Analyst/Engineer II to plan and approve validation tasks across manufacturing processes, equipment, and information systems.

Under the Validation Section Manager, you will perform validation activities and contribute to quality program deployment at the plant. The role requires experience in validation investigations, SOP review, CAPA integration, and supporting regulatory audits.