Please read the following job description thoroughly to ensure you are the right fit for this role before applying. We are seeking a highly motivated and detail-oriented Process Validation Engineer with 1-3 years of experience to join the team in Tucson, AZ. The Process Validation Engineer will be 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. Other duties as assigned by management. Qualifications: Bachelor’s degree in Engineering, Life Sciences, or a related field. 1-3 years of experience in process validation within a regulated industry (pharmaceutical, medical device, biotechnology, . Strong understanding of process validation principles, techniques, and industry standards. Familiarity with regulatory requirements (FDA, ISO) and Good Manufacturing Practices (GMP). Excellent analytical, problem-solving, and critical-thinking skills. Strong written and verbal communication skills. Ability to work both independently and as part of a multidisciplinary team. Detail-oriented with strong organizational and time-management skills. Proficient in Microsoft Office Suite (Word and Excel), Google Workspace Preferred Qualifications: Experience with statistical analysis software (., Minitab, JMP). Previous experience in a cleanroom or controlled environment. Knowledge of Six Sigma or Lean methodologies. Job ID: 1024107