Process Technician

Process Technician – Filling & Material Preparation

The Process Technician supports clinical pharmaceutical manufacturing by preparing materials, operating and maintaining production equipment, and executing aseptic processes in a regulated cleanroom environment. This role works on an 11:00 a.m. to 7:30 p.m. shift and contributes directly to the manufacture of batches for clinical development, ensuring compliance with GMP, GLP, and FDA requirements while helping to optimize production efficiency and product quality.

Responsibilities

• Manufacture batches by performing complete material preparation and handling activities according to established procedures and quality standards.
• Operate production equipment used in filling and material preparation, ensuring safe, efficient, and compliant operation.
• Take ownership of assigned equipment, including routine checks, basic troubleshooting, and coordination of necessary maintenance.
• Assist in placing orders for materials and consumables and perform material bookings and transactions in SAP.
• Conduct inventory management activities to ensure adequate stock levels and accurate inventory records.
• Perform sampling activities according to the defined sampling plan and document results in compliance with regulatory and internal requirements.
• Prepare and set up format tools and components required for specific production runs and formats.
• Perform autoclaving of materials and equipment into Grade B cleanroom areas, following aseptic and sterilization procedures.
• Adjust machinery parameters as needed to maintain process performance, product quality, and regulatory compliance.
• Collaborate with Plant Engineering to maintain machines and ensure equipment remains in a qualified and reliable state.
• Support the implementation of production procedures designed to optimize manufacturing processes and meet regulatory requirements.
• Assist process development teams in developing scalable manufacturing processes that improve product yield and reduce costs.
• Support maintenance activities on production equipment as needed, following safety and GMP guidelines.
• Research and help implement new methods, technologies, or process improvements to enhance manufacturing operations.
• Carry out engineering-related activities associated with production, equipment, or process optimization.
• Clean, disinfect, and sanitize manufacturing rooms, equipment, and related areas in accordance with cleanroom and GMP standards.
• Wear and properly use required safety gear and cleanroom gowning while performing duties.
• Perform physical tasks such as standing, sitting, walking, climbing stairs or ladders, kneeling, and crouching as required by daily operations.
• Maintain accurate documentation and adhere to GDP (Good Documentation Practice) for all manufacturing and support activities.

Essential Skills

• Experience working in a pharmaceutical, cleanroom, laboratory, manufacturing, or related technical environment.
• Knowledge of and adherence to GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) standards.
• Experience with aseptic technique and cleanroom operations, including gowning and behavior in controlled environments.
• Familiarity with FDA-regulated environments and associated regulatory expectations.
• Ability to follow and apply GDP (Good Documentation Practice) in all records and documentation.
• Competence in handling laboratory or manufacturing equipment and performing technical procedures safely and accurately.
• Ability to operate production machinery and adjust parameters within defined limits.
• Capability to perform material preparation, including weighing, dispensing, and staging for production.
• Experience or ability to learn SAP or similar systems for material ordering and booking.
• Strong attention to detail and ability to follow standard operating procedures and sampling plans.
• Physical ability to stand, sit, walk, climb stairs or ladders, kneel, and crouch, and to wear safety gear and cleanroom gowning for extended periods.
• Entry-level chemistry or life science education or equivalent experience in a laboratory or technical setting.
• Alternatively, at least 2+ years of experience in an FDA/GMP cleanroom or…