Senior Validation Engineer

Location: Tempe, AZ

Duration: 12-Month Contract

Pay Rate: $60–$63/hour

Schedule: Monday–Friday, 8:00 AM–5:00 PM

Work Arrangement: Hybrid – Minimum 3 days onsite per week

Position Summary

Our client is seeking a Senior Process Engineer to support qualification and validation activities for New Product Introduction (NPI) initiatives in Tempe, AZ.

This role will focus on the qualification and validation of manufacturing processes, equipment, and related technologies required for new product manufacturing. The ideal candidate will have experience developing and executing validation protocols, supporting equipment and process qualifications, and maintaining technical documentation within a regulated manufacturing environment.

Key Responsibilities

• Support qualification and validation activities for new product introduction and manufacturing process development projects.
• Develop, review, and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), as applicable.
• Support equipment qualification and process validation to ensure manufacturing processes consistently meet established requirements.
• Analyze validation data, document results, and prepare comprehensive validation reports.
• Collaborate with process engineering, manufacturing, quality, and cross-functional teams to resolve validation-related issues.
• Ensure validation activities are conducted in accordance with established quality procedures and applicable regulatory requirements.
• Maintain accurate validation documentation, technical records, and project deliverables within the applicable quality management system.
• Support deviation investigations, troubleshooting, and corrective actions related to qualification and validation activities.
• Utilize validation management software and statistical tools to organize, execute, and document validation activities.
• Contribute to continuous improvement initiatives involving validation processes, documentation, and manufacturing systems.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or another relevant engineering discipline.
• Approximately 2–6 years of relevant experience in process validation, equipment qualification, or manufacturing engineering.
• Hands-on experience supporting qualification and validation activities in a manufacturing environment.
• Understanding of validation methodologies, including IQ, OQ, and PQ.
• Experience developing, executing, or reviewing validation protocols and reports.
• Strong technical writing, analytical, and problem-solving skills.
• Ability to work collaboratively with cross-functional engineering and quality teams.

Preferred Qualifications

• Experience in medical device manufacturing, pharmaceutical, biotechnology, or another regulated industry.
• Familiarity with ValGenesis or comparable validation management software.
• Experience with Agile document quality management systems or electronic document management platforms.
• Familiarity with Minitab or other statistical analysis tools.
• Knowledge of GMP, ISO standards, and regulated manufacturing documentation requirements.
• Experience supporting New Product Introduction (NPI) projects.