Process Validation Engineer (Life Sciences)

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 /

Full-time