Process Engineer III/IV
Company: AGC Biologics
Posted on: June 22, 2022
AGC Biologics is a leading global Contract Development and
Manufacturing Organization, with a deep commitment to improving
life quality by bringing new biopharmaceuticals to market. Because
of our dedication to building and empowering our internal teams,
AGC Biologics is an innovative leader in the industry with an
extensive network of cGMP facilities in the US, Europe and Asia. As
such, we deliver a deep expertise, dynamic solutions and
technologies, as well as customized services for the scale-up and
cGMP manufacturing of protein-based therapeutics. We forge
exceptionally strong partnerships with our clients, and we never
lose sight of our pledge to deliver a reliable and compliant drug
substance supply. Right. On time. For more information, visit
www.agcbio.com .SummaryThe Process Engineer III/IV primary
responsibilities are to support the Colorado manufacturing facility
through technical assistance as it relates to manufacturing and
process systems with an emphasis on upstream operations including
Cell Culture and Harvest operations. The focus of the role is on
ensuring manufacturing equipment, plant utilities and facilities
are operating as intended to meet the requirements for
biopharmaceutical manufacturing. The Systems Engineering function
will provide tactical support of ongoing plant operations and
strategic implementation of engineering projects to meet the
changing needs of the business. Must be a SME in key critical
engineering disciplines (Process, Electrical, Automation,
Mechanical, HVAC, etc.) to support the startup, commissioning and
lifecycle support of new and existing/legacy systems at the Boulder
Colorado manufacturing facilityPrinciple Responsibilities
- System Owner of all process equipment for assigned functional
- Liaison between MSAT, capital projects, automation and
maintenance support groups in support of manufacturing.
- Develop / embed technical knowledge on Mammalian manufacturing
equipment and processes in the EOS department.
- Mentor the development of a cross-functional engineering team
(mechanical, electrical, automation)
- Manage resolution of major equipment breakdowns and quality
issues in the suites by driving a robust root cause analysis (RCA)
- Provide SME support to Manufacturing and other departments for
the design and operation of process equipment.
- Conduct troubleshooting and technical analyses on manufacturing
equipment and processes.
- Assist with tech transfer of new Mammalian processes into the
- Interact with the Reliability Engineer to strengthen the
preventative maintenance program to eliminate equipment failure
- Provide troubleshooting support to the Mammalian process
- Implement new projects in the manufacturing area, while meeting
all of the quality standards set forth by the company and
government regulationsKnowledge, Skills & Abilities
- Adaptable; must be willing to remain flexible to accommodate
changing business conditions, work requirements and scheduling
needs in a rapidly changing environment.
- Demonstrated attention to detail with the ability to focus on
the project or task at hand and consistently deliver error free
- Must be comfortable working in a fast paced environment and
available to provide on-call support when needed
- Excellent organizational skills with ability to multi-task and
- Demonstrated proficiency with all Windows based programs,
knowledgeable with any CMMS program
- Excellent verbal and written communication skills; ability to
communicate with multi-level audiences.
- Demonstrated ability to write investigations and standard
operating procedures (SOP's)
- Demonstrated ability to develop and maintain clear and accurate
documentation of process equipment or manufacturing
- BS/MS in Engineering (Chemical, Biotechnology, Mechanical, or
Electrical) or Master highly preferable.
- Minimum of 5 years of relevant industry experience (Biotech /
GMP manufacturing environment).
- Prior experience with Upstream and Downstream unit operations
(centrifugation, filtration, precipitation, chromatography,
bioreactors, CIP/SIP, mass flow technology, etc.)
- Minimum of 5 years of troubleshooting process automated systems
in Biotech/Pharma Process. Experience with instrumentation and
control with PCS, SCADA, DCS, Historian, MES systems
- Experience in the design and operation of Biopharmaceutical
facilities, both manufacturing and support systems.
- Experience with single use manufacturing technology operations
- Experience leading technical teams.
- Experience writing reports for senior colleagues outlining new
concepts, testing outcomes, and ongoing efficiency.
- Equivalent education and experience may substitute for stated
requirementsCompensation Range$97,917 - $155,400 annuallyAGC
Biologics offers a highly competitive compensation package and a
friendly, collaborative culture that values personal initiative and
professional achievement. AGC Biologics is an equal opportunity
employer. All qualified applicants will---receive consideration for
employment without regard to age, ancestry, color, family or
medical care leave, gender identity or expression, genetic
information, marital status, medical condition, national origin,
physical or mental disability, political affiliation, protected
veteran status, race, religion, sexual orientation, or any other
characteristic protected by applicable laws, regulations and
Keywords: AGC Biologics, Boulder , Process Engineer III/IV, Engineering , Boulder, Colorado
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