Engineer II
Company: GENENTECH
Location: Oceanside
Posted on: January 12, 2021
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Job Description:
The Position **This is a local hire only. Relocation is not
budgeted for this role.** We are seeking an enthusiastic and highly
motivated engineer dedicated to providing scientific and technical
support to downstream bioprocess manufacturing operations. This
role is responsible for receiving new processes from Process
Development or other manufacturing sites, process monitoring and
analysis, process performance troubleshooting, as well as
establishment and maintenance of the process validated state and
ongoing process improvement. The selected candidate will also
support the design, installation, commissioning and validation of
GMP processes and equipment originating from tech transfers and/or
capital projects. Focus will also be placed on providing support
for existing processes and equipment through continuous improvement
activities by leading and working with multi-functional teams. This
is an ideal position for an individual interested in leadership
opportunities and providing scientific and technical judgment as
part of a team responsible for delivering high quality
biopharmaceutical products to patients. Integrity, accountability,
and strong dedication to the patients we serve are critical to this
role. Provide technical expertise to support process tech transfers
and/or expense/capital projects through budget development,
schedule development, resource planning, design, construction,
commissioning and qualification activities Provide technical
expertise for the commissioning and validation of processes,
process equipment and associated utilities through teams composed
of cross functional SMEs. Provide technical leadership to monitor
process health through process monitoring, trouble shooting of
processes and process equipment. Liaise with site functions -
Manufacturing, Process Development, Planning, QA, QC, Operations,
and Regulatory Affairs to support the process transfer and project
implementation. Participate in gap analyses and risk assessments to
support the tech transfers. Author tech transfer related projects
plans, assessments, and process validation protocols Review and
provide recommendations on design drawings, which may include PFDs
that incorporate mass balances and P&IDs, which include all
line sizing, instrumentation and control philosophies. Interact
with vendors concerning contracts of critical financial value and
select vendors based on the most appropriate combination of price,
quality and delivery. This often involves negotiations of a complex
and/or controversial nature. Review and approve vendor information
packages, including drawings and specifications. Make
recommendations to senior staff. Develop, manage and integrate key
aspects of critical projects such as budget, schedules, resource
planning, problem solving, etc, in alignment with corporate
objectives. Generate controlled documents to support the start-up,
operation, validation and maintenance of equipment and complex
systems. Provide key input into the validation of process equipment
and associated utilities. Direct manufacturing and operations staff
in the execution of validation protocols. Provide technical support
to manufacturing. Provide technical assessments for investigations,
validation and change control. Manage corrective actions as a
result of investigations. Ensures the integration of environmental
health, safety, and security into the business processes, systems,
and programs while reporting safety and environmental incidents
including injuries, illnesses, and safety suggestions within one's
functional area. Fosters a positive safety culture in which no one
gets hurt. Job Requirements Education and Experience BS/MS/PhD in a
biological or engineering (preferred) discipline - Chemical
Engineering, Biochemical Engineering, Biotechnology, Biochemistry,
or related field. 5+ years experience in downstream biologics
process development, technology transfer, pilot plant, or
manufacturing support. 5+ years applicable equipment and process
system experience. Knowledge, Skills and Abilities Solid technical
understanding of downstream processes (harvest, chromatography,
viral filtration, and/or UF/DF) Thorough knowledge of
biopharmaceutical manufacturing, process equipment and supporting
utility systems, especially those related to sanitary and sterile
operations Experience in the design, installation and operations of
GMP processes and equipment. Process troubleshooting and
experimental design Prior experience in biological/viral commercial
manufacturing facility Validation experience related to equipment,
clean utility and process systems, including requirements for
documentation and testing. Thorough knowledge of cGMP guidelines,
experience in generation of controlled documents and extensive
experience in equipment start-up and validation. Excellent
organization and time utilization skills. Excellent communication
skills, both written and verbal. Use creativity and innovation to
address urgent and/or complex problems and propose solutions. Work
Environment/Physical Demands/Safety Considerations Work in standard
office environment. May work in the clean room environment that
requires 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. #LI-CA1 #ptcareers Who We Are
Genentech, a member of the Roche group and founder of the
biotechnology industry, is dedicated to pursuing groundbreaking
science to discover and develop medicines for people with serious
and life-threatening diseases. To solve the world's most complex
health challenges, we ask bigger questions that challenge our
industry and the boundaries of science to transform society. Our
transformational discoveries include the first targeted antibody
for cancer and the first medicine for primary progressive multiple
sclerosis. Diversity and Inclusion (D&I) are critical to the
success of our company and our impact on society. We believe that
by championing diversity of background, thought and experience, we
can foster a sense of belonging and provide an environment where
every employee feels valued, included, and able to contribute their
best for the patients we serve. We're focused on attracting,
retaining, developing and advancing our people to their full
potential by rewarding bold ways of thinking and integrating
inclusive behaviors into every aspect of our work. The next step is
yours. To apply today, click on the "Apply for this job" 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 Production Engineering
COMPANY/DIVISION Pharmaceuticals SCHEDULE Full time JOB TYPE
Regular
Keywords: GENENTECH, Oceanside , Engineer II, Other , Oceanside, California
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