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 and cell and gene therapies. 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.
The Process Engineer III primary responsibilities are to support new product introduction and optimization projects as well as the ongoing operations at the Bothell, WA site through technical assistance as it relates to manufacturing and process systems. The focus of the role is on ensuring manufacturing equipment and facilities are operating as intended to meet the requirements for biopharmaceutical manufacturing. The Process Engineering function will provide tactical support of ongoing plant operations and strategic implementation of engineering projects to meet the changing needs of the business.
- Support facility and process design and startup.
- Develop / embed technical knowledge on 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, Microbial, and Cell Therapy processes into the facility.
- Interact with the Reliability Engineer to strengthen the preventative maintenance program to eliminate equipment failure modes.
- 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:
- Experience with Cell and Gene Therapy, Mammalian, and / or Microbial manufacturing
- Knowledge of process transfer and scale up methodology.
- Experience with GMP documentation, facility and equipment validation, and process optimization.
- Experience preparing and executing CAPEX projects.
- 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)
- BS/MS in Engineering (Chemical, Biotechnology, Mechanical, or Electrical) or Master highly preferable.
- PMP certification desired.
- Lean / Six Sigma certification desirable
- Minimum of 6 years of relevant industry experience (Biotech / GMP manufacturing environment).
- Prior experience with Cell and Gene Therapy equipment and processes
- Upstream and Downstream unit operations (centrifugation, filtration, precipitation, chromatography, bioreactors, CIP/SIP, mass flow technology, etc.) desirable.
- Minimum of 3 years troubleshooting process automated systems in Biotech/Pharma Process.
- Experience in the design and operation of Biopharmaceutical CGT facilities, both manufacturing and support systems.
- Project Management and coordination experience associated with the execution of capital projects in an industrial environment is required.
- Experience with single use manufacturing technology operations and troubleshooting.
- Experience managing a project team.
- Experience writing reports for senior colleagues outlining new concepts, testing outcomes, and ongoing efficiency.
- Demonstrated ability to develop and maintain clear and accurate documentation of process equipment or manufacturing processes.
- Equivalent education and experience may substitute for stated requirements
Compensation range for this role is $92,843 - $118,843 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