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Lead, Manufacturing Technician (Days) Full-time

at GENENTECH in Oregon (Published at 03-04-2020)

The Position
Please note this is a day shfit position, 6:00am to 6:30pm Thursday through Saturday (every other Wednesday)
Main Purpose of the Position :
Under the direction of Manufacturing Supervisor, provide leadership role to 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:
Provide leadership role to other Technicians
Passion and drive to develop and maintain a LEAN culture dedicated to providing the best results for our internal and external customers
Embraces World Class 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
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 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)
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
Perform bulk thaw, dilution, and formulation operations
Performing manual inspection of empty vials and filled product with a focus on quality and 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 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. 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.
High school diploma or equivalent AND
Graduate of a two-year Associates Degree program in Electrical/mechanical Technology (or equivalent) is a plus
Candidates must have a minimum of 6 months? cGMP aseptic operations experience. Some college work preferred or relevant experience. 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. Target industries include pharmaceutical, biotechnology, biomedical, electronic, and chemical, food, cosmetics, and/or other medical industries.
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 email. Must possess basic typing skills.
Job descriptions are not intended, and should not be construed to be an all-inclusive list of all responsibilities, skills, efforts, or working conditions associated with a job. While this description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add, or remove duties and to assign other duties as necessary.
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page . Job Facts JOB FUNCTION
General Manufacturing COMPANY/DIVISION
Pharmaceuticals SCHEDULE
Full time JOB TYPE

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