Senior Process Engineer - NPI & GMP (Hybrid, Tempe)

System One Clinical & Science; Tempe (AZ); Hybrid; USD 77,000 - 85,000; Part time

Benefits offered by this job

Health benefits

401(k) plan

Dental and vision insurance

Job summary

System One Clinical & Science seeks a Senior Process Engineer in Tempe, AZ for a contract role. You will drive new product introduction process development, focusing on manufacturing processes, technology, and procedures required to bring new products to market.

The ideal candidate has 2+ years of experience, a bachelor’s degree in engineering, and familiarity with GMP/regulatory environments. This role requires hands-on site work and collaboration with cross-functional teams.

Qualifications

• Bachelor’s degree in engineering is required.
• 2+ years of relevant work experience.
• Lean Six Sigma Green Belt Certification or above (preferred). In FDA regulated environments is a plus.

Responsibilities

• Provide engineering support for new product and process introductions, ensuring activities follow NPD procedures.
• Ensure quality of process and product per operation and material specifications.
• Assist in equipment selection and design based on specifications, reliability, and regulatory requirements.
• Support capital acquisition activities including equipment specifications, contract negotiation, installation, and validation.
• Write and maintain operations, troubleshooting, and maintenance manuals.

Education

Bachelor’s degree in engineering

Bachelor's degree in Industrial or Systems Engineering

Job description

System One Clinical & Science seeks a Senior Process Engineer in Tempe, AZ for a contract role. You will drive new product introduction process development, focusing on manufacturing processes, technology, and procedures required to bring new products to market.

The ideal candidate has 2+ years of experience, a bachelor’s degree in engineering, and familiarity with GMP/regulatory environments. This role requires hands-on site work and collaboration with cross-functional teams.