QA Validation Engineer II — Lead Validation & GMP Compliance

Veg Group; Barceloneta (PR); On-site; USD 75,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&E G), a Pinnaql company, seeks a QA Validation Analyst/Engineer to plan and approve validation tasks, and possibly execute validation activities under supervision.

You will help implement the Validation quality program at the plant and may supervise contract validation resources. The role emphasizes ensuring quality systems compliance, conducting investigations, reviewing validation documentation, and supporting audits in a GMP environment.

Qualifications

• Bachelor's degree in Biology, Chemistry or Engineering.
• 2+ years of experience in Manufacturing, Quality or Engineering preferred.
• Must be fully bilingual (English/Spanish).
• Strong communication and problem-solving skills.
• Knowledge of API, Bulk Drug or Finished goods manufacturing regulations a plus.

Responsibilities

• Participate in implementation and maintenance of the Quality System to meet regulatory requirements.
• Execute validation tasks to ensure equipment, utilities, facilities, and processes are in a validated state.
• Review and author validation documentation; support CAPA systems as required.
• Assist with investigations and corrective actions related to validation findings.
• Support regulatory and third-party audits as needed.

Skills

Kaye Validator

TempTales

Temperature mapping

Equipment/Utilities Validation

CIP/SIP Cleaning validation

Education

Bachelor's degree in Biology, Chemistry or Engineering

Tools

Kaye Validator

TempTales

Job description

Validation & Engineering Group, Inc. (V&E G), a Pinnaql company, seeks a QA Validation Analyst/Engineer to plan and approve validation tasks, and possibly execute validation activities under supervision.

You will help implement the Validation quality program at the plant and may supervise contract validation resources. The role emphasizes ensuring quality systems compliance, conducting investigations, reviewing validation documentation, and supporting audits in a GMP environment.