Process Validation Engineer

Process Validation Engineer

Pay Rate/Range: $37.50

Location: Tucson, AZ

Duration: 1 year

Job Summary:

We are seeking a highly motivated and detail-oriented Process Validation Engineer to join our team. The successful candidate will be responsible for developing, executing, and reporting on process validation and verification activities to ensure manufacturing processes comply with regulatory standards and internal quality requirements. This role will work cross-functionally to drive continuous process improvement and ensure a robust state of validation across operations.

Key Responsibilities:

Develop, author, and execute process validation and/or process verification protocols and final reports.

Conduct risk assessments and define validation strategies for both new and existing processes.

Analyze and interpret validation data, ensuring accuracy and compliance with regulatory and company standards.

Collaborate with cross-functional teams including Manufacturing, Quality, and Design Transfer to resolve validation-related issues and implement corrective actions.

Support process optimization efforts and contribute to continuous improvement initiatives.

Ensure validation practices are compliant with FDA, ISO, GMP, and internal SOPs.

Train manufacturing and quality personnel on validation processes and requirements.

Maintain thorough and audit-ready documentation for all validation activities.

Perform other tasks as assigned by management. Qualifications:

Required:

Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.

1-3 years of relevant experience in process validation within a regulated industry (pharma, biotech, or medical devices).

Solid understanding of process validation principles, statistical techniques, and industry best practices.

Knowledge of FDA, ISO standards, and GMP regulations.

Excellent analytical and problem-solving skills.

Effective written and verbal communication abilities.

Strong organizational and time management skills.

Proficiency in Microsoft Office Suite and Google Workspace. Preferred:

Experience with statistical analysis software (e.g., Minitab, JMP).

Prior work in cleanroom or controlled manufacturing environments.

Familiarity with Lean or Six Sigma methodologies and tools.

Benefits (employee contribution):

Health insurance

Health savings account

Dental insurance

Vision insurance

Flexible spending accounts

Life insurance

Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.