Validation Engineer

Virtue America; United States; Remoto; USD 41.000 - 55.000; Part-time

Descrizione del lavoro

Virtue America is seeking an entry-level Validation Engineer to support validation and qualification activities in a regulated pharmaceutical, biotech, or medical device environment. The role focuses on learning and applying IQ, OQ, and PQ protocols, ensuring cGMP compliance and proper technical documentation.

The ideal candidate has an engineering background, strong analytical skills, and effective communication to collaborate with QA, Manufacturing, Engineering, and Automation teams on

Competenze

• Understanding of IQ, OQ, PQ concepts.
• Familiarity with GMP and FDA regulations.
• Knowledge of validation lifecycle documentation.
• Ability to review engineering drawings and specs.
• Strong analytical and communication skills.

Mansioni

• Support IQ, OQ, and PQ protocol execution.
• Develop and maintain validation protocols and reports.
• Review specs and drawings.
• Document test results and deviations.
• Assist with change control and risk assessments.
• Collaborate with QA, Manufacturing, Engineering, and Automation.
• Ensure compliance with cGMP and applicable standards.

Conoscenze

Analytical skills

Communication

Problem-solving

Team collaboration

Attention to detail

Formazione

Bachelor's degree in Mechanical Engineering

Descrizione del lavoro

Job Title: Validation Engineer – Entry Level

Location: Remote

Employment Type: Contract

Experience: 0–2 Years

Job Summary

We are seeking a motivated Entry-Level Validation Engineer to support validation and qualification activities in a regulated pharmaceutical, biotechnology, or medical device manufacturing environment. The ideal candidate will have an engineering or life sciences background and a basic understanding of validation principles, GMP requirements, and technical documentation.

Key Responsibilities

• Support validation and qualification activities for manufacturing equipment, utilities, facilities, and processes.
• Assist in preparing and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Develop and maintain validation protocols, test scripts, reports, and supporting documentation.
• Review engineering specifications, equipment drawings, and technical documents.
• Support process validation, cleaning validation, and equipment qualification activities.
• Document test results, deviations, discrepancies, and corrective actions.
• Assist with change control, risk assessments, and validation lifecycle documentation.
• Collaborate with Quality Assurance, Manufacturing, Engineering, and Automation teams.
• Ensure compliance with cGMP, FDA regulations, and applicable industry standards.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, or a related field.
• 0–2 years of experience in validation, qualification, quality, or manufacturing engineering.
• Basic understanding of IQ, OQ, PQ, and validation lifecycle concepts.
• Familiarity with GMP, GDP, and FDA regulatory requirements.
• Knowledge of technical documentation and engineering procedures.
• Strong analytical, communication, and problem-solving skills.