Position Title: Validation Engineer

Work Location: Tucson, AZ 85755

Assignment Duration: 12 Months

Work Schedule: 40 hours/week

Work Arrangement: Onsite

Position Summary:

• 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.

Key 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.

Qualification & Experience:

• 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.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 39.00/hr.