Validation Engineer

TalentBurst, an Inc 5000 company; Tucson (AZ); On-site; USD 48,216 - 61,992; Full time

Job summary

A reputable engineering firm is seeking a Process Validation Engineer I in Tucson, AZ. This entry-level position involves ensuring compliance and driving operational integrity in a regulated manufacturing environment, focusing on process validation. Candidates should have a Bachelor's Degree in Engineering or Life Science and 1-3 years of relevant experience. Strong technical writing and analytical skills are important. Competitive hourly pay range of $35.00 – $45.00.

Qualifications

• 1-3 years of experience in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably FDA).

Responsibilities

• Develop, write, review, and execute process validation protocols.
• Conduct risk assessments and develop validation strategies.
• Analyze process validation data for compliance.

Skills

Strong technical writing, analytical, and problem-solving skills

Knowledge of cGMP and regulatory standards

Strong understanding of process validation principles and techniques

Risk assessment and validation strategy development

Education

Bachelor's Degree in Engineering or Life Science

Job description

Overview

Position: Process Validation Engineer I, Req#: ROCGJP00037522

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

Duration: 12+ Months Contract

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

Company: TalentBurst, 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.

Required Education/Experience

• 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.

Key Accountabilities

• 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.

Seniority level

• Entry level

Employment type

• Contract

Job function

• Engineering, Research, and Science

Industries

• Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research

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