Aseptic Process Engineer - Scale-Up & Validation

Saigepartners; Lathrop (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

Saigepartners is seeking a Process Engineer to design, validate, and optimize aseptic food manufacturing processes in a fast-paced plant environment in California. You will develop process documentation, support pilot and commercial production, and lead equipment qualification and process validation activities.

The role requires strong technical writing, cross‑functional collaboration, and a commitment to GMP/FSMA and continuous improvement.

Qualifications

• Bachelor's or Master’s degree in Food, Chemical, or Mechanical Engineering.
• 5+ years of experience in food manufacturing or food processing, preferably in aseptic processing.
• Experience with process scale‑up, equipment qualification, PFDs/P&IDs, CAD software, PLC/HMI systems, and food processing equipment.
• Strong technical writing, troubleshooting, root‑cause analysis, project management, and cross‑functional collaboration skills.
• Commitment to continuous improvement and operational excellence.

Responsibilities

• Design and optimize aseptic manufacturing processes, including PFDs, P&IDs, SOPs, and batch records.
• Lead equipment qualification (IQ/OQ/PQ), process validation, and scale‑up from pilot to commercial production.
• Support production through troubleshooting, process improvements, and yield optimization.
• Ensure compliance with GMP, FSMA, and sanitary design requirements.
• Evaluate equipment, manufacturing capability, and implement cost‑saving and capital improvement projects.
• Collaborate with Quality, Production, Maintenance, Supply Chain, and customers on new product development and operational improvements.
• Train operators and maintenance personnel on equipment operation and sanitation.

Skills

Process engineering

Aseptic processing

Technical writing

Project management

Cross-functional collaboration

Education

Bachelor's or Master’s degree in Food, Chemical, or Mechanical Engineering

Tools

CAD software

PLC/HMI systems

Job description

Saigepartners is seeking a Process Engineer to design, validate, and optimize aseptic food manufacturing processes in a fast-paced plant environment in California. You will develop process documentation, support pilot and commercial production, and lead equipment qualification and process validation activities.

The role requires strong technical writing, cross‑functional collaboration, and a commitment to GMP/FSMA and continuous improvement.