Process Engineer(Auto 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

Title or Role: Process Engineer Automated Inspection of Syringes

Compensation: Up to $80.00 per hour

Location: Onsite Holly Springs, North Carolina

Length of Contract: Up to one year+

Position Description

We are seeking a highly skilled and driven Process Engineer to lead the development, implementation, and qualification of our client's state-of-the-art Syringe Visual Inspection System. In this role, you will bridge the gap between advanced automation and stringent regulatory compliance within a new biologics manufacturing facility. You will be responsible for the end-to-end lifecycle of the automated visual inspection process- integrating robotics, programming high-speed vision systems, and ensuring the final system meets all FDA and global regulatory requirements for biologics.

Key Responsibilities

1. Process Development & Technical Ownership

• Lead the design, configuration, and optimization of automated inspection systems for pre-filled syringes.
• Define recipe parameters for particle detection, cosmetic defects, container closure integrity, and fill-volume verification.
• Partner with automation and robotics engineers to seamlessly integrate product-handling robotics with the vision inspection system.
• Conduct feasibility studies, defect engineering, and challenge-pack creation to establish robust baseline detection capabilities.

2. Validation & Qualification (Equipment & Processes)

• Author and execute Lifecycle Validation documentation, including User Requirement Specifications (URS), Functional Specifications (FS), Installation/Operational/Performance Qualifications (IQ/OQ/PQ), and Computer System Validation (CSV) protocol.
• Develop and execute the Knapp Study methodology to prove automated system equivalence (or superiority) to manual visual inspection.
• Manage deviation investigations, root-cause analysis (RCA), and implement Corrective and Preventive Actions (CAPA) related to the inspection system.

3. Regulatory Compliance & Quality Assurance

• Ensure all systems and processes strictly comply with FDA guidelines (specifically USP <790> and USP <1790> ), EU Annex 1, and 21 CFR Part 11.
• Serve as the technical Subject Matter Expert (SME) during internal audits and regulatory FDA inspections.
• Maintain comprehensive traceability matrices linking regulatory requirements to system functionality and testing.

4. Cross-Functional Collaboration

• Collaborate with Formulation, Filling, Packaging, and Quality Control teams to ensure smooth tech transfer and process integration.
• Provide technical training and draft Standard Operating Procedures (SOPs) for operations and maintenance personnel.

Qualifications

• Experience: 3-5+ years of experience in a GMP biologics or pharmaceutical manufacturing environment, with a dedicated focus on automated inspection platform.
• Visual Inspection Expertise: Deep understanding of automated inspection technologies (e.g., Brevetti, Seidenader, Client/Syntegon platforms), camera optics, lighting configurations, and image processing software.
• Robotics & Automation: Familiarity with robotic handling systems (e.g., FANUC, Staubli, or similar cleanroom-rated robotics) and PLC/SCADA control network.
• Regulatory Knowledge: Strong working knowledge of cGMP, 21 CFR Part 11, and USP <790> /<1790> guidelines.
• Problem Solving: Proven experience utilizing Six Sigma tools (DMAIC, FMEA, Fishbone) for root-cause analysis

Education & Certifications

• Bachelor's or Master's degree in Chemical Engineering, Mechanical Engineering, Bioengineering, Automation/Robotics Engineering, or a related technical discipline