Validation Engineer

Overview

Position: Process Validation Engineer I, Req#: ROCGJP

Location: Tucson, AZ (100% Onsite only). No Relocation assistance will be provided by Talent Burst and or Client.

Duration: 12+ Months Contract

Base pay range: $35.00/hr - $45.00/hr

Company: Talent Burst, an Inc 5000 company

Job Description: We are seeking a proactive Validation Engineer with 1-3 years of experience in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably FDA) to ensure compliance and drive operational integrity. This is an on-site position that focuses on process validation. The validation engineer will focus on process validation vs. equipment qualification.

• Bachelor's Degree in Engineering or Life Science.
• 1-3 years of experience in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably FDA).
• The validation engineer will focus on process validation vs. equipment qualification.
• Strong technical writing, analytical, and problem-solving skills.
• Knowledge of cGMP and regulatory standards.
• Strong understanding of process validation principles, techniques, and industry standards.

• Develop, write, review, and execute process validation/process verification protocols and reports.
• Conduct risk assessments and develop validation strategies for new and existing processes.
• Analyze and interpret process validation data, ensuring accuracy, completeness, and adherence to regulatory and internal requirements.
• Collaborate with Manufacturing, Quality, Design Transfer Operations, and other departments to resolve validation issues and implement corrective actions.
• Participate in process optimization and continuous improvement initiatives to enhance quality and efficiency. Ensure compliance with FDA, ISO, and other relevant regulatory guidelines, as well as adherence to internal requirements. Provide training and guidance to manufacturing and quality personnel on validation processes and procedures.
• Maintain process validation documentation and ensure traceability and accessibility for audits and inspections.
• Other duties as assigned by management.

• Entry level

• Contract

• Engineering, Research, and Science

• Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research

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