Process Engineer - Automated Inspection of Syringes

Process Engineer Automated Inspection of Syringes

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.

• 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.

• Validation & Qualification (Equipment & Process)
• 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) protocols.
• 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.

• Regulatory Compliance & Quality Assurance
• 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.

• 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.

• Experience:
  
  3–5+ years of experience in a GMP biologics or pharmaceutical manufacturing environment, with a dedicated focus on automated inspection platforms.
• 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 networks.
• 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.

Equal Opportunity

Employer:

RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Pay Transparency: RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization.

About RCM: RCM is publicly traded on Nasdaq under the symbol RCMT. RCM is a business and technology solutions provider with world-class talent in key market segments. We help design, build, and enable the Industries of Tomorrow, Today. Operating at the intersection of resources, critical infrastructure, and modernization of industries, RCM is a provider of services in Life Sciences, Data & Solutions (IT), Healthcare, Engineering, Aerospace & Defense, and Process & Industrial.

Disclaimer:
This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.