Process Automation Engineer II/Senior
Posted on: September 19, 2022
The Automation Engineers are an integral part of the Oceanside
Automation team within Genentech's Manufacturing Science and
Technology team and serve the site's broader needs in our
digitization efforts. The Oceanside manufacturing site is a
large-molecule drug substance facility designated as a
Pivotal/Launch site to help advance Genentech/Roche pipeline
products at the Phase III and Commercial launch stages. We are
looking for individuals who are comfortable with ambiguity, have an
entrepreneurial spirit within a GMP environment, have demonstrated
strong Pharma Technical behaviors, and have an agile/network
mindset. The ability to collaborate is crucial, and success in the
role will require the individual to thrive in a team environment
and not act solely as an individual contributor.
In this role, you will be responsible for providing automation and
instrumentation and control engineering capabilities and expertise
to the various functions including generating qualification
protocols and maintaining the validated state of systems and
processes. You will focus on providing long-term support for
existing and future facilities with respect to the automation and
instrumentation and control systems for process, utility and
building systems and provide technical input to automation
impacting projects with small and/or focused scope.
Essential Job Functions
- Perform automation and instrumentation and control engineering
design services for existing facility projects, including upgrades
and capacity expansions, equipment upgrading and
- Produce and review design drawings and specification documents
(URS, FS, DS, etc.).
- Generate, execute, and review Installation, Operational, and
Performance Qualification protocols.
- Generate, review, and approve GMP Lifecycle Documents (e.g.
risk documents, trace matrices, periodic review, etc.)
- Initiate, execute, and track progress of change
- Support the start-up and troubleshooting of automation and
critical process utility systems.
- Support the plant that operates 24x7 to assess discrepant
events and changes for automation impact, deliver automation
solutions to resolve operational issues, assist in troubleshooting
and providing real time on floor support of manufacturing
operations, and participate in site coordination meetings.
- Adhere to site SOPs and WIs for daily and project deliverables
and provide improvements to business processes.
- Support inspection activities to present automation design and
- Attendance and participation in department and staff
- Maintain training qualifications.
- Support equipment/software FAT, field testing and
- 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
- Authoring new batches recipes within the MES (Syncade)
- Analyze existing workflows or manufacturing procedures and
- Handling manufacturing support calls related to the MES
Education and Experience
- Bachelor's or Master's degree in Engineering (Chemical,
Mechanical, Electrical, or Computer Science preferred) or related
scientific discipline and 4 years experience, or Master's degree in
Engineering (Chemical, Mechanical, Electrical, or Computer Science
preferred) and 2 years experience.
- Minimum of 4 years applicable automation and/or instrument and
control system experience.
- Minimum of 1 year in the pharmaceutical/biotech industry/GMP
Knowledge, Skills and Abilities
- Experience with Biopharmaceutical manufacturing, design or/and
- Knowledge of process, utility and building control
- Knowledge of GMP guidelines, experience in generation of
- Qualification experience related to control and computer
- Ability to generate engineering drawings and
- Knowledge of ISA standards, PID control theories and
- Knowledge of PLC (programmable logic controllers), and
associated programming languages (RSLogix Preferred).
- Practical knowledge of DeltaV programming, and associated
- Demonstrate good interpersonal skills with an ability to
interact well with a variety of personalities, discipline skills
and educational levels.
- Demonstrate good written and verbal communication
- Ability to comply with cGMP requirements (gowning,
documentation, and procedures) for performing work within the
- Ability to work most of the time independently with direct
Work Environment/Physical Demands/Safety Considerations
- Work in a standard office environment.
- May work in the clean room environment that 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 clean room
- May work with hazardous materials and chemicals.
Candidates may be hired at a Engineer II or Senior Engineer level
depending on experience.
Genentech offers full relocation support, along with a
comprehensive total rewards package for this role.
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.
Unless entitled to a reasonable accommodation under applicable law,
employees are required to be fully vaccinated against COVID-19 in
accordance with customer requirements, the company's health and
safety obligations and/or applicable law or guidelines.
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.
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. For
more information about equal employment opportunity, visit our
Genentech Careers Homepage.
Keywords: Roche, Oceanside , Process Automation Engineer II/Senior, Engineering , Oceanside, California
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