Overview
Validation Engineer Jobs in Tucson, AZ at Sharp Decisions
Title: Validation Engineer
Company: Sharp Decisions
Location: Tucson, AZ
Job Title : Validation Engineer
Pay Rate : $42/hr on W2
Location : Tucson, AZ
Duration : 12 Months Contract with a possible extension
***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
