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 .

SUMMARY:

The Process Engineer, Senior 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 facility.

PRINCIPLE RESPONSIBILITIES:

• System Owner of all process equipment for assigned functional areas.
• 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) process.
• 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 facility.
• Interact with the Reliability Engineer to strengthen the preventative maintenance program to eliminate equipment failure modes.
• Provide troubleshooting support to the Mammalian process systems
• Implement new projects in the manufacturing area, while meeting all of the quality standards set forth by the company and government regulations

KNOWLEDGE, 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 results
• 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 prioritize.
• 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 processes.

EDUCATION/EXPERIENCE:

• BS in Engineering (Chemical, Biotechnology, Mechanical, or Electrical) or Master’s highly preferable.
• Minimum of 8 years of relevant industry experience troubleshooting process automated systems in Biotech/Pharma Process. Experience with instrumentation and control with PCS, SCADA, DCS, Historian, MES systems preferred.
• Prior experience with Upstream and Downstream unit operations (centrifugation, filtration, precipitation, chromatography, bioreactors, CIP/SIP, mass flow technology, etc.)
• Experience in the design and operation of Biopharmaceutical facilities, both manufacturing and support systems.
• Experience with single use manufacturing technology operations and troubleshooting.
• 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 requirements

COMPENSATION RANGE:

$112,583 - $135,100 annually

AGC 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 ordinances. EOE