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Manufacturing Technician - BioProcess

Company: Genentech
Location: Vacaville
Posted on: June 24, 2022

Job Description:

The Position

Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness. Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer. Performs media/buffer solution preparation operations. Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Responsible for being proficient in one functional area. Understands and applies biological, chemical and mechanical principles and techniques.

Job Responsibilities

Essential

* Operate systems that clean and sterilize tanks and filtration systems.
* Prepare solutions for the production process.
* Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
* Trouble shoot equipment and process problems.
* Comply with safety requirements, cGMP, SOP and manufacturing documentation.
* Use of automation to perform production operations.
* Provide support to Manufacturing to meet production demands.
* Operate automated systems for equipment operation.
* Assemble and prepare equipment for production.
* Exhibit detail oriented documentation skills.
* Communicate effectively and ability to work in a team environment.
* Exhibit professional interpersonal skills.
* Work with coworkers and supervisor to effectively troubleshoot minor equipment and process issues.
* A good working knowledge of biopharm technology and processes.
* Trained and skilled in all operational procedures of at least one manufacturing department.
* Demonstrated ability to independently document and record information related to the process.
* Occasionally makes routine decisions based on experience. Identifies and suggests solutions to common basic problems.
* Recognizes non-routine problems, investigates and suggests potential solutions.
* Judgment is required in resolving problems and making routine recommendations.
* Ability to recognize deviation from accepted practices is required.
* All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
* Follows 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 a positive safety culture in which no one gets hurt.

Supplementary Responsibilities

* Operate fermenters, centrifuges, other harvest systems and protein purifications units.
* Operate and clean fixed tank and filtration systems.
* Operate large scale column chromatography systems.
* Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20L batch feed fermenters; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.
* Perform Solution Preparation activities (media and buffer make-up).
* Clean, assemble, and sterilize equipment using glass washers and autoclaves.
* Perform automated CIP and SIP of fixed equipment.

Job Requirements

Education and Experience

* Degree in Life Sciences or Engineering and 1 year related experience, or Associate degree and 3 years experience, or High school and 5 years experience.
* Biotech certificate from approved program.

Knowledge, Skills and Abilities

* Strong oral and written communication skills.
* Familiarity of computer-based systems.
* Background in fermentation.
* Ability to receive, interpret and provide basic information and materials involved with the day to day activities of performing the job.

Work Environment/Physical Demands/Safety Considerations

* Ability to work a flexible shift structure
* Expected to be on feet for 8 to 10 hours a day.
* May climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility.
* Lifting up to 25lbs may be required.
* Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no make up or jewelry can be worn when working in the clean room environment.
* May work with hazardous materials and chemicals.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Keywords: Genentech, Vacaville , Manufacturing Technician - BioProcess, Professions , Vacaville, California

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