Process Validation Engineer

On site in Tucson

This is in the Engineering category

We are seeking a highly motivated and detail-oriented Process Validation Engineer with 1-3 years of experience to join our team. 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, etc.).

• 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 (e.g., Minitab, JMP).

• Previous experience in a cleanroom or controlled environment.

• Knowledge of Six Sigma or Lean methodologies.

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