Manufacturing Technician - Finished Goods

Roche•Hillsboro, OR

3d•$43,300 - $80,300•Onsite

About The Position

Under the direction of the Process Unit Leader, the Inspection Technician performs a wide variety of tasks and operations that are required to support filling, inspection and packaging of sterile pharmaceutical products in a state-of-the-art, automated filling 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/Roche 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 Safety and Quality 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.

Requirements

High school diploma or equivalent.
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.
Proficiency in the English language- reading, writing, and communication.
Must be able to work all shifts (1st, 2"d, or 3rd), required overtime as needed, able to lift 45 pounds, and stand for extended periods of time.
Must be able to successfully pass all job-related tests and certifications required for working in a cGMP, quality environment including but not limited to: inspections and GMP requirements to perform essential functions of the job .
Must re-qualify every year on all job-related tests and certifications as job or qualifications require.
All candidates must pass a vision acuity and color discrimination test.

Nice To Haves

Graduate of a two-year Associates Degree program in Electrical/Mechanical Technology (or equivalent).
1 to 2 years (within the last 7 years) experience in the operation of complex mechanical equipment used in the washing, filling, conveying, sealing, inspection and packaging of products/containers is highly desirable.

Responsibilities

Adhere to all plant safety policies and procedures and proactively identify unsafe conditions.
Perform safety and housekeeping audits as required.
Assist in set up, change over, and test run equipment for various-sized vials and packages as required.
Supporting the Operations Specialist Maintenance, and/or outside services in the repair, maintenance, and calibration of GNE Systems as required.
Perform training of other Technicians.
Assist in the development of operational SOP's and training materials.
Execute production recipes, check-in equipment, and perform material movements using automated computer software applications (SAP and MES systems).
Operate all formulation, sterile filling, inspection, and final vial packaging equipment in the plant.
Perform preparation of sterile components.
Assist in the cleaning, set-up, sterilization, and disassembly on a variety of processing equipment.
Support Component Preparation and Compounding (thaw, dilution, and formulation operations).
Performing manual inspection of empty vials and filled product with a focus on quality & efficiency
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.