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