Title: Validation Engineer
Location: Oro Valley, AZ 85755, USA
Duration: 12 months (Possible extension/conversion based on performance and budget)
Hourly Rate on W2: $39-42
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***
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.
--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.
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