Process Engineer(Auto Inspection

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+

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.

• 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.

• 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.

• Ensure all systems and processes strictly comply with FDA guidelines (specifically USP and USP ), 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.

• 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.

• 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 / guidelines.
• Problem Solving:
  Proven experience utilizing Six Sigma tools (DMAIC, FMEA, Fishbone) for root-cause analysis

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