Process Technician

Job Title:

Process Technician Job Description

The Process Technician supports clinical manufacturing operations by performing in-process checks, visual inspection, and packaging activities in compliance with cGMP, while also managing documentation, inventory, and SAP transactions. This role splits time between hands‑on work in a clean room environment and desk‑based documentation tasks to ensure high‑quality, compliant production of aseptically filled units.

• Perform in-process control (IPC) checks during filling activities to ensure all physical parameters meet established specifications.
• Conduct visual inspection of filled and finished units, including vials, syringes, and related components, to identify and remove nonconforming products.
• Verify correct labeling, sealing, and final packaging of each batch in accordance with cGMP and standard operating procedures (SOPs).
• Ensure all activities follow current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), internal SOPs, and applicable regulatory requirements.
• Perform calibration and routine maintenance of inspection and packaging equipment to maintain accuracy and reliability.
• Package inspected batches according to defined procedures and documentation requirements.
• Place and track orders in SAP to support production and packaging activities.
• Ensure proper documentation and evaluation of process and inspection data, maintaining complete and accurate records.
• Review batch records, inspection records, and related documentation for completeness, accuracy, and compliance.
• Generate, update, and maintain SOPs and quality control (QC) forms in alignment with cGMP requirements.
• Conduct inventory management activities, including monitoring stock levels of materials, components, and supplies used in production and inspection.
• Collaborate with quality, laboratory, and manufacturing teams to support continuous improvement and maintain a high standard of product quality.

• High school diploma (HS Diploma) with 1–2 years of experience in an FDA‑regulated cGMP environment such as pharmaceutical, medical device, or food manufacturing.
• Hands‑on experience working in a laboratory or clean room environment.
• Demonstrated understanding of FDA, cGMP, and GLP principles and their application in daily operations.
• Ability to follow and apply SOPs and quality control procedures accurately and consistently.
• Proficiency with Microsoft Office applications for documentation, data entry, and reporting.
• Capability to perform detailed visual inspections and in‑process checks with a high level of attention to detail.
• Experience working in compliance‑focused environments, including clean room and aseptic operations.
• Basic familiarity with SAP or similar enterprise systems for placing orders and managing data.

• Previous experience in pharmaceutical, biotechnology, medical device, or food production environments under FDA oversight.
• Experience working with vials, aseptically prefilled syringe systems, cartridges, or similar sterile products.
• Prior exposure to quality control, laboratory operations, or clean room production processes.
• Strong organizational skills to manage documentation, inventory, and multiple tasks simultaneously.
• Ability to write, update, and improve SOPs and QC forms in alignment with regulatory and company standards.
• Comfort working in a contract development and manufacturing organization (CDMO) environment supporting clinical development and commercial manufacturing.
• Strong communication skills to collaborate effectively with cross‑functional teams in manufacturing, quality, and laboratory operations.

This role is based in a US clinical manufacturing facility located within the Illinois Science & Technology Park in Skokie, Illinois. The Process Technician divides time between a controlled clean room environment, where aseptic filling, inspection, and packaging activities take place, and an office setting used for documentation, SAP work, and data evaluation. The facility operates under FDA, cGMP, and GLP requirements, with a strong focus on quality, regulatory compliance, and support…