California, United States of America
Job Responsibilities – Upstream Manufacturing
Senior Technician (N3) / Master Technician (N4)
Primary focus is the cleaning, sterilization and operation of fixed vessel systems for media preparation, fermentation, and harvest operations; perform seed train operations; perform dispensing of components; handle and aliquot hazardous materials.
Follow established safety and environmental guidelines and procedures for all work performed.
Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions
Fosters safe work practices
Operate systems that clean and sterilize tanks and filtration systems.
Prepare materials for the production process.
Exhibit detail oriented documentation skills to ensure Right-First-Time operations (e.g. tickets, labels, equipment reading)
Escalate process issues as necessary to ensure resolution of issue
Comply with cGMP, SOP and manufacturing documentation.
Use automation to perform production and equipment operations.
Provide support to Manufacturing to meet production demands.
Assemble and prepare equipment for production.
Communicate effectively and professionally work in a team environment.
Be able to perform all routine operations
Train other technicians in group and individual settings
Troubleshoot process equipment and systems
Serve as an example and advocate of ingrained quality
Champion safety improvements and encourages safe work practices in department
Contribute to a LEAN work environment by acting as a change agent and utilizing OE Tools
Contribute to the improvement of training material and practices
Serve as department representative on cross-functional teams
Demonstrate Roche Leadership Competencies within Department and to the site
Be able to act as SME to regulatory agencies
Lead troubleshooting efforts to resolve complex process issues
Education and Experience
AS/BS/BA in Biological Sciences, Physical Sciences, or Engineering or Biotech certificate from approved program
Minimum of three years in large-scale GMP production environment with proven track record
Knowledge, Skills, and Abilities
Strong oral and written communication skills
Familiarity of computer-based systems
Demonstrated application of LEAN methodologies to enable problem solving and continuous improvement
Ability to read and understand engineering documents is desirable
Experience in creation and revision of Standard Operating Procedures and Manufacturing Formula is desirable
Work Environment/Physical Demands/Safety Considerations
Must be able work weekends, off-shifts, and overtime as required (12-hour shifts).
No make-up or jewelry can be worn when working in the clean room environment.
Work on and around pressurized tanks, housings and equipment, which are connected by piping and pumps and services by pressurized steam, water, air and cleaning/sanitizing chemicals systems.
Don gowning in the form of hospital scrubs, coveralls and safety toe footwear with shoe covers being multiple times per shift.
Don lab coats as well as safety glass/goggles, gloves (nitrile or latex) multiple times per shift.
Handle and work with hazardous materials and chemicals per OSHA guidelines.
Usage of hearing protection and dust masks may be required.
Expected to be on feet standing or walking for up to 90% of shift.
Travel up to 30 flights of stairs each shift to maneuver within the facility.
Work Environment/Physical Demands/Safety Considerations cont…
Utilize keyboard and mouse to interact with process automation systems as well as email, word processing/spreadsheets and other online computer systems.
Lift up to 40lb(18.2kg) loads multiple times per shift and carry up to 30 lbs(13.6kg). Team lifting will be used for heavier or awkward lifts/carries up to 20 times per shift.
Push or pull materials with up to 50lb-force with full body. Utilize mechanical means or powered industrial trucks for forces beyond the 50lb-force limit up to 10 times per shift.
Manipulation of process equipment, connections and raw materials may require bending and reaching as well as repetitive twisting gripping hand motions. Where mechanical stress or pressure can be transmitted to the palm and the fingers during hand tool use, especially when large forces must be exerted. Forces should not exceed 22 pounds/inch2 (10 kg/cm2).
In order to operate powered industrial trucks, employee must pass a DOT Physical which includes: Blood Pressure <140/90, Vision must be at least 20/40 in both eyes with or without corrective lenses, pass color vision and whisper hearing test as well as have a valid Driver’s License
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.
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At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.
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