Job Description

Our client, a world leader in diagnostics and life sciences, is looking for a " Process Validation Engineer " based out of Tucson, AZ.  Please review the details below:

Job Duration: Long Term Contract (Possibility Of Further Extension)

Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K

Responsible for developing and executing process validation and/or process verification protocols and reports to ensure that manufacturing processes are compliant with regulatory requirements and company standards. This role involves collaborating with cross- functional teams to support continuous improvement and maintenance of validated processes.

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.
  

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related field.
  
• Experience in process validation within a regulated industry (pharmaceutical, medical device, biotechnology, etc.)
  
• Strong understanding of process validation principles, techniques, and industry standards.
  
• Familiarity with regulatory requirements (FDA, ISO) and Good Manufacturing Practices (GMP).
  
• Proficient in Microsoft Office Suite (Word and Excel), Google Workspace
  
• Experience with statistical analysis software (e.g., Minitab, JMP) is preferred.
  
• Knowledge of Six Sigma or Lean methodologies is preferred.
  

If interested, kindly share your updated resume at hr@dawarconsulting.com / akansha@dawarconsulting.com

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