Senior Process Engineer - NPI & Manufacturing (Hybrid)

System One, Inc.; Tempe (AZ); Hybrid; USD 77,000 - 85,000; Part time

Job summary

System One, Inc. is seeking a Senior Process Engineer in Tempe, AZ for a contract role. The position focuses on new product introductions, process development, and manufacturing process optimization to ensure compliance with GMP and safety standards.

The role requires at least 2 years of relevant experience and a Bachelor's degree in engineering. Hybrid work model; responsibilities include equipment evaluation, process validation, and cross-functional coordination to meet project timelines and

Qualifications

• 2+ years of relevant work experience.
• Bachelor's degree in engineering required.

Responsibilities

• Provide engineering support for new product and process introductions, ensuring activities are completed and documented per NPD procedures.
• Ensure quality of process and product as defined in operating and material specs.
• Assist in equipment selection and design based on specifications, reliability, and regulatory requirements.
• Support capital acquisition activities, including equipment specification, contract negotiation, installation and validation.
• Write operations manuals, troubleshooting manuals, and maintenance manuals.
• Analyze equipment to establish operating data and conduct tests and result analyses.
• Reduce product time to market while meeting regulatory requirements, deadlines, and costs.
• Participate in PFMEA, control plan, SOPs, and PPAP generation for product transfers and launches.
• Complete capability studies for in-process inspection and document results.
• Conduct qualifications, validations, and MSA studies for new products/processes; review validation docs.
• Hands-on work at the manufacturing site to implement new processes.
• Communicate with stakeholders for project success.
• Provide training for manufacturing teams.
• Ensure GMP and safety procedures are followed.

Skills

years of experience

Bachelor's degree in engineering

Education

Bachelor's degree in engineering

Job description

System One, Inc. is seeking a Senior Process Engineer in Tempe, AZ for a contract role. The position focuses on new product introductions, process development, and manufacturing process optimization to ensure compliance with GMP and safety standards.

The role requires at least 2 years of relevant experience and a Bachelor's degree in engineering. Hybrid work model; responsibilities include equipment evaluation, process validation, and cross-functional coordination to meet project timelines and