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Validation Engineer
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Mindlance
Tucson, AZ (In Person)
Full-Time
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Job Description
Validation Engineer#26-13701
Tucson, AZ
All On-site 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.
EEO:
"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of- Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.