Manufacturing Associate Technician - Packaging

Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Operations organization at HTO is divided into 2 value streams, which combine to produce millions of units of life-saving medicine every year to patients around the world.

There are two openings: One for days (M-TH 5:30am to 4pm and one for Swing shift (M-TH 3pm to 1:30am) Under the direction of the Process Unit Lead or other qualified Operations Specialist, perform a wide variety of tasks and operations that are required to formulate, fill, inspect and package sterile pharmaceutical products in a state-of-the-art, automated production and packaging facility. Troubleshoot, maintain, and assemble all production equipment as required. Assist the Operations Specialist on major equipment overhauls, repairs, and installations as necessary. All operations will be carried out in compliance with cGMPs, Standard Operating Procedures (SOPs), product recipes, and Genentech standards. In addition to performing the responsibilities/tasks below, the successful candidate will need to demonstrate the following traits and capabilities: Passion and drive to develop and maintain a culture of continuous improvement, dedicated to providing the best results for our internal and external customers. Embraces Lean Manufacturing/Six Sigma tools (e.g., 5S, Kaizen) and leverages data analytics of system performance to identify opportunities for improvement and deliver reduced costs and increased efficiency. Collaborates with Cross-Functional teams (Quality, Engineering, Assets) to pilot new process enhancements. Adhere to all plant safety policies and procedures and proactively identify unsafe conditions. Assist in cleaning, set up, change over, and running of equipment for the inspection or packaging of various-sized vials, pre-filled syringes, and devices as required. Supporting the Engineers, Maintenance Mechanics, and/or outside services in the repair, maintenance, and calibration of GNE Systems as required. This includes executing user-performed and routine maintenance. Perform training of other Technicians, and assist in the development and improvement of HTO SOP's and training materials. Execute production recipes, check-in equipment, and perform material movements using automated computer software applications (SAP and MES systems). Prior to start-up, during processing, and at the completion of the manufacturing process, perform all documentation and clerical functions to provide the proper accountability and traceability of components and finished product.  Responsible for identifying, reporting, and documenting process deviations or atypical events in accordance with site Standard Operating Procedures (SOPs) Knowledge of the automation systems that include SAP, Manufacturing Execution Systems (MES), PiProcess Book, Programmable Logic Controllers (PLC) and Human Machine Interfaces (HMI). Troubleshooting and identification of resolution for mechanical failures in production. Performing manual and semi-automated inspection of filled product vials with a focus on quality and efficiency. Conduct environmental monitoring activities in the manufacturing areas as required including routine cleaning and housekeeping activities to maintain environmental grade of each manufacturing area. At the start and finish of each shift, report and make recommendations regarding equipment, supplies, required repairs, process concerns, safety concerns, and areas for improvement in reliability, yield, and efficiency. Actively participates in a teamwork environment that maintains a high performance culture. Strictly adhere to Good Documentation Principles (GDP’s), and the ability to accurately complete Batch Production Records (BPRs), logbooks, and forms to maintain a high level of data integrity.

High school diploma or equivalent and two years