Senior Manufacturing Technican, Drug Product
Company: Genentech, Inc.
Location: South San Francisco
Posted on: June 6, 2021
The manufacturing technician is responsible for producing
innovative biotherapeutic medicine by interfacing with highly
automated production systems in a cGMP manufacturing environment.
The individual will operate production equipment for our Bulk
Processing, Filling/Aseptic Operations, and Inspection. This may
include process monitoring, in-process sampling, bulk formulation,
fill line operations, lyophilization, bulk freeze/thaw, transfer
operations, final vial inspection, and equipment set up/
changeover. The individual will be required to work in and maintain
a clean room environment with aseptic processing in accordance with
Standard Operating Procedures (SOPs). Must maintain batch records
and associated documentation to comply with regulatory requirements
and current Good Manufacturing Practices (cGMP). Area of work must
remain in a high state of inspection readiness at all times.
ResponsibilitiesWe are seeking applicants for this position who
possess the following skills and experience: Able to operate in a
clean room environment by adhering to aseptic processing
qualifications and requirements. Able to perform equipment set up
and change over. Demonstrate ability to train others on equipment
and documentation systems. Adhere to proper documentation
(manufacturing tickets and standard operating procedures). Complete
and review production documents in real time. Participate in
on-going training programs to enhance technical proficiency.
Provide basic troubleshooting guidance or production related
equipment. Inspect empty vials and filled product with a focus on
quality and efficiency. Communicate effectively and ability to work
in a team environment. Professional interpersonal skills. Embraces
principles and behaviors consistent with the needs of the business.
Continuously in search of ways to maintain the highest levels of
productivity. Actively participates in a team environment that
maintains a high performance culture. Able to problem solve and
manage projects from start through completion. Demonstrate mastery
of equipment by performing troubleshooting.Qualifications
Bachelor's degree preferably in Life Sciences or engineering, or
Associate degree and 5+ years related experience , o r High School
diploma and 5+ years related experience. Biotech certificate from
approved program desirable.Understands the theory, concepts, and
regulations behind biopharmaceutical technology and processes.
Ability to understand high levels of automation and technical
process knowledge within area of responsibility. Understand aseptic
and clean room principles 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. Can pass a vision
acuity and color discrimination test as well as routine medical
screenings for conditions that could impact the manufacturing
environment. Passion and drive to develop and maintain a culture
dedicated to providing the best results for our internal and
external customers. Excellent oral and written communication
skills. Demonstrate problem solving skills. Lean production system
experience desired. Detail oriented documentation skills. Physical
Demands/Work Environment/Safety Considerations Schedule could
include a non-rotating 3 or 4-day (12 hour shift including one
weekend day), evening or night hours. Expected to be on feet for 8
to 13 hours a day. Climb upwards of 6 flights of stairs a day to
maneuver within the manufacturing facility. Able to lift and carry
up to 40 lbs. Push and/or pull with force of 50lbs with full body,
and Push/Pull force of 24lbs with arms only may be required.
Working within a clean room environment requires: Gowning in the
form of hospital scrubs, coveralls, gloves, and steel toe boots. No
make up or jewelry can be worn when working in the cleanroom
environment. Comfortable working in areas with large mechanical
equipment, process piping, pumps, pressurized vessels, which can
occasionally create a loud working environment. Must wear personal
protective equipment in accordance with workplace hazards. Work
with hazardous materials and chemicals.
Keywords: Genentech, Inc., South San Francisco , Senior Manufacturing Technican, Drug Product, Other , South San Francisco, California
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