The focus of Hillsboro Technical Operations (HTO) is Drug Product manufacturing (Component Prep & Compounding, Liquid/Lyophilized Filling, Automated/Manual Inspection, Packaging/Finished Products and Distribution.)
Under the direction of the Process Unit Lead, perform a wide variety of tasks and operations that are required to formulate, fill, and package sterile pharmaceutical products in a state-of-the-art, automated production and packaging facility. Troubleshoot, maintain, assemble, install, and repair all electronic, mechanical, and instrumentation devices on production equipment as required. Assist 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:
Passion and drive to develop and maintain a LEAN culture dedicated to providing the best results for our internal and external customers.
Embraces Class A principles and behaviors.
Continuously in search of ways to maintain the highest levels of productivity.
Actively participates in a teamwork environment that maintains a high performance culture.
Adhere to all plant safety policies and procedures and proactively identify unsafe conditions.
Perform safety and housekeeping audits as required.
Set up, change over, and test run equipment for various-sized vials and packages as required. Make mechanical and electrical adjustments necessary for the correct operation of the equipment.
Act as a troubleshooter, moving between all areas to assist related crafts in the performance of their duties. Diagnose problems involving electronic, electrical, instrumentation, and pneumatic hydraulic control systems. Work with the maintenance department and/or outside services to repair, maintain, and calibrate these systems as required.
Perform or coordinate major and minor overhauls of production equipment as needed.
Perform training of other Operations Specialists.
Assist in the development of plant SOP’s and training materials.
Execute production recipes, check-in equipment, and perform material movements using automated computer software applications (SAP and MES systems).
Assist and/or operate all sterile filling and final vial packaging equipment in the plant. Perform material handling in the plant as required.
Perform preparation of sterile components.
Assist in the cleaning, set-up, sterilization, and performance of maintenance on a variety of processing equipment.
Perform bulk thaw, dilution, and formulation operations.
Conduct environmental monitoring activities in the manufacturing areas as required.
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.
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.
Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
Perform cleaning and housekeeping duties as required.
Please note this is a fixed TERM position for a two year duration. Fixed TERM roles are eligible for medical benefits and other total rewards programs. This position is also eligible for two $2,500 completion bonuses (total of $5,000), paid at the end of the first and second year of successful continuous employment.
To apply for this job please visit careers.gene.com.