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 Project Engineer III’s primary responsibility is the management and execution of all project related activities carried out within their assigned areas of responsibility. This role functions in a cross functional capacity providing direction, identifying/resolving issues, organizing work assignments for equipment/manufacturing rooms/people, etc. and encouraging collaboration between essentially all functional areas. This includes the management of internal company resources, (assets, financial) as well as external professional engineering and design firms, etc.
- Act as a liaison between Operations, Technical Services and Quality for key initiatives and projects that require manpower, rooms and equipment from the manufacturing area.
- Monitor, analyze, and helps to control key metrics for areas and projects that are key to meet company objectives.
- Lead teams to align projects, develop and execute plans, and deliver results.
- Ensure all required company, site and FDA regulation are adhered to, with emphasis on cGMP and their applications.
- Track ongoing projects, including forecasting of internal/external resource utilization.
- Prioritize projects and make critical decisions related to assigned projects with minimal guidance and oversight.
- Ensure activities required to lead projects is performed independently and finished work is in the form of project plans, project documents, and executed deliverables.
- Participate in the capital budget development process by proposing, justifying and prioritizing projects.
- Manage and resolve technical issues or changes arising throughout project life cycle(s) while ensuring the overall project objectives of scope, cost and schedule are adhered to.
- Manage site activities necessary for successful execution of project(s); ensure these are completed as necessary to tie in with the overall project execution.
- Prepare and deliver updates on accomplishment of project timelines. Support facility and process design and startup.
- Mentor the development of a cross-functional engineering team (mechanical, electrical, automation)
- 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.
KNOWLEDGE, SKILLS & ABILITIES:
- Ability to deliver CAPEX projects of varying complexity up to $10M in value.
- Experience with Cell and Gene Therapy, Mammalian, and / or Microbial manufacturing space design/construction
- Demonstrated 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)
- Demonstrated ability to develop and maintain clear and accurate documentation for project management
- BS in Engineering (Chemical, Biotechnology, Mechanical, or Electrical) required; MS highly preferable.
- Minimum of 6 years of relevant industry experience (Biotech / GMP manufacturing environment) required; experience with Cell and Gene Therapy equipment and processes desired.
- PMP certification desired.
- Lean / Six Sigma certification desirable
- Experience with Upstream and Downstream unit operations (centrifugation, filtration, precipitation, chromatography, bioreactors, CIP/SIP, mass flow technology, etc.) desirable.
- Experience in the design, construction, and validation 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 leading a project team
- Experience writing reports for senior colleagues outlining new concepts, testing outcomes, and ongoing efficiency.
- Equivalent education and experience may substitute for stated requirements
$92,900 - $118,800 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