JV
Validation Engineer
Accepting applicationsJobs via Dice · Arizona, United States
Full-Time Associate aiarmaterf
Posted
6h ago
Category
Test
Experience
Associate
Country
United States
Validation Engineer Job Opening
Validation Engineer
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.
Location: On-site
Focus: Process Validation
Pay Range: $39/hr - $42/hr (depending on experience)
Responsibilities
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.
Perform other duties as assigned by management.
Qualifications
Bachelor's Degree in Engineering or Life Science.
Strong technical writing, analytical, and problem-solving skills.
Knowledge of cGMP and regulatory standards.
Strong understanding of process validation principles, techniques, and industry standards.
Equal Opportunity Employer
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Validation Engineer
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.
Location: On-site
Focus: Process Validation
Pay Range: $39/hr - $42/hr (depending on experience)
Responsibilities
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.
Perform other duties as assigned by management.
Qualifications
Bachelor's Degree in Engineering or Life Science.
Strong technical writing, analytical, and problem-solving skills.
Knowledge of cGMP and regulatory standards.
Strong understanding of process validation principles, techniques, and industry standards.
Equal Opportunity Employer
Show more Show less