Genentech Operational Specialist
Performs electrical or mechanical troubleshooting to determine problems in non-functioning electro-mechanical equipment used in the manufacturing process. Dismantles, adjusts, repairs and assembles equipment according to layout plans, blueprints, operating or repair manuals, rough sketches or drawings. Uses test and diagnostic equipment to perform checkouts. Rebuilds manufacturing equipment as required. May perform equipment modifications as directed by manufacturing engineers.
Please note this is a Day Shift position, Sunday through Tuesday (every other Wed), 6:00am to 6:30pm.
Main Purpose of the Position:
Under the direction of Manufacturing Supervisor or other qualified Operations Specialist, 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.
Qualifications / Requirements:
Proficiency in the English language - reading, writing, and communication. Must be able to work all shifts (1st, 2nd, or 3rd), required overtime as needed, able to lift 45 pounds, and stand for extended period of time. In addition, all candidates must pass a vision acuity and color discrimination test.
• High school diploma or equivalent.
• Graduate of a two-year Associates Degree program in Electrical/Mechanical Technology (or equivalent) is highly desirable.
Five years recent (within the last 7 years) experience in the set-up, repair and operation of complex mechanical equipment used in the washing, filling, conveying, sealing, inspection and packaging of products/containers. This experience must include equipment set-up, changeover, mechanical/electrical repairs, disassembly, and preventative maintenance. Target industries include pharmaceutical, biotechnology, biomedical, electronic, and chemical, food, cosmetics, and/or other medical industries.
Special Skills or Abilities:
Ability to read Piping and Instrument Diagrams, electrical drawings, blueprints, PLC ladder logic, etc. Ability to analyze instrumentation and electronic maintenance problems and take appropriate corrective measures. Knowledge of electrical, hydraulic, and pneumatic principles.
Must be computer literate, including ability to interface with computer systems and PLC-based logic. Must be comfortable working with Microsoft suite (Word, Excel, PowerPoint), navigating through web pages and e-mail. Must possess basic typing skills.
Location: Hillsboro, OR
Application Method: Please send cover letter & resume to: email@example.com
Base Pay: DOQ