Automation Process Engineer - Syringe Inspection

RCM Technologies, Inc.; Holly Springs (NC); On-site; USD 66,000 - 110,000; Full time

Job summary

RCM Technologies, Inc. is seeking a Process Engineer to lead the development, validation, and qualification of an automated syringe visual inspection system for a new biologics facility. The role bridges advanced automation with regulatory compliance, integrating robotics, high-speed vision, and CSC controls.

Responsibilities include authoring validation documents, optimizing inspection parameters, and ensuring adherence to USP, EU Annex 1, and 21 CFR Part 11 throughout the product lifecycle.

Qualifications

• 3–5+ years in GMP biologics/pharmaceutical manufacturing with automated inspection focus.
• Experience with automated inspection platforms, vision systems, and robotics interfaces.
• Strong working knowledge of GMP, FDA 21 CFR Part 11, and regulatory guidelines.

Responsibilities

• Lead design, configuration, and optimization of automated syringe inspection systems.
• Define recipe parameters for defect and fill-volume verification.
• Collaborate with automation/robotics to integrate handling with the vision system.
• Prepare validation and qualification documentation (IQ/OQ/PQ, CSV) and support audits.

Skills

GMP biologics experience

Regulatory compliance

Six Sigma / DMAIC

Automation & Robotics

Vision system experience

Education

Bachelor's or Master's in Chemical/Mechanical/Bioengineering or Automation/Robotics

Tools

Brevetti vision systems

Seidenader platforms

Client/Syntegon platforms

Job description

RCM Technologies, Inc. is seeking a Process Engineer to lead the development, validation, and qualification of an automated syringe visual inspection system for a new biologics facility. The role bridges advanced automation with regulatory compliance, integrating robotics, high-speed vision, and CSC controls.

Responsibilities include authoring validation documents, optimizing inspection parameters, and ensuring adherence to USP, EU Annex 1, and 21 CFR Part 11 throughout the product lifecycle.