Performs functions associated with all manufacturing operations, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components, subassemblies and final assemblies. Uses sophisticated programs to collect and evaluate operating data to conduct on-line adjustments to products, instruments or equipment. Determines and may assist in developing methods and procedures to control or modify the manufacturing process. Works with engineers in conducting experiments.
Responsible for producing innovative bio-therapeutic medicine by interfacing with highly automated production systems and controls in current Good Manufacturing Practices (cGMP) environment; maintaining areas in high state of inspection preparedness, and utilizing business systems for inventory and process management. Maintain records to comply with regulatory requirements utilizing cGMP and Standard Operating Procedures (SOPs).
Participate in the routine production of mammalian cell culture products within the Vacaville Manufacturing Facility, operating in at least one of the following production areas:
· Upstream Manufacturing (UM):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.
· Downstream Manufacturing (DM): Responsibilities include the operation and cleaning of fixed tank systems, the operation and cleaning of filtration systems, large-scale buffer preparation, and the operation of column chromatography systems; perform dispensing of components; handle and aliquot hazardous materials.
· Production Services (PS):Provide support to Manufacturing to meet production demands. Duties include but are not limited to: CIP/SIP of portable and Freeze/Thaw tanks; clean, assemble, and autoclave 20L fermenters; prepare and autoclave manufacturing assemblies; autoclave solutions; clean and Kanban, glassware, parts and equipment; perform weighing and kitting of components; handle and aliquot hazardous materials; provide quality materials and service to our customers.
· 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
Education and Experience
· AS/BS/BA in Biological Sciences, Physical Sciences, or Engineering or
· Combination of college coursework and related work experience or
· Biotech certificate from approved program
Knowledge, Skills, and Abilities
· Strong oral and written communication skills
· Familiarity of computer-based systems
· Ability to receive, interpret and provide basic information and materials involved with the day to day activities of performing the job
· Ability to read and understand engineering documents is desirable
· Experience in creation and revision of SOPs and Manufacturing Formula is desirable
· Must be able to work weekends, off-shifts, and overtime as required
· 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
· 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
· 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.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.