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.
The Engineering Co-Op, Project Engineer is a current student registered with a CO based College/University who is able to commit to a minimum of 30 hours per week between the hours of 8 am to 5pm Monday to Friday during the 2023 fall semester and ideally 40 hours per week during summer break. The primary responsibility is to support the management and execution of all project related activities carried out within the scope of the Engineering CAPEX (Capital Expenditure) Plan. This role functions in a cross functional capacity by assisting in setting direction, identifying/resolving issues, organizing work assignments for equipment/utilities/building areas/people, etc. and encouraging collaboration between all functional areas. This includes monitoring of internal company resources, (assets, financial) as well as interaction with external professional engineering and design firms, etc.
What to Expect in our Co-op Program:
Expand your technical and professional skills in a real-world setting. AGC Biologics co-ops are given meaningful work, support, and mentorship from experienced managers and key business leaders. There is the potential to gain knowledge and experience in a variety of ways by exploring opportunities associated with your major.
- We offer competitive compensation, flexible dress code policy, and a state of the art work environment.
- Our co-ops are a key talent pipeline for full-time employment opportunities after graduation at our many locations.
- Act as a liaison between Engineering / Maintenance, Operations, Technical Services and Quality for key initiatives and projects that require manpower, space, utilities and equipment from the manufacturing, laboratory and warehouse area(s).
- Monitor, analyze, and help to control key metrics for areas and projects that are required to meet company objectives.
- Participate on teams to help align projects, develop and execute plans, and deliver results.
- Ensure all required company, site and FDA regulations 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 guidance and oversight.
- Ensure activities required to manage projects is performed collaboratively and finished work is in the form of project plans, project documents, and executed deliverables.
- Support and participate in the capital budget development process by obtaining preliminary information and meeting with end users.
- Support in the management and resolution of technical issues or changes arising throughout the project life cycle(s) while ensuring the overall project objectives of scope, cost and schedule are adhered to.
- Assist in managing 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.
- Support and collaborate with a cross-functional engineering team (maintenance, utility, calibration process and automation)
- Interact with Global Engineering network in order to harmonize processes and share best practices
KNOWLEDGE, SKILLS & EXPERIENCES GAINED:
- Exposure in preparing and executing CAPEX projects of varying complexity from $750K thru $10M in value.
- Knowledge and skills gained in regards to Cell and Gene Therapy, Viral Vector, Mammalian, and / or Microbial manufacturing space design and construction
- Gain knowledge of process transfer and scale up methodology for Cell Therapy and Viral Vector processes into the facility.
- Accumulate knowledge and experience in regards to FDA regulated GMP documentation, standard operating procedures (SOP’s), facility and equipment validation, and process optimization.
- Learn techniques around organization, prioritization and multi-tasking.
- Gain skills using multiple windows based programs, engineering related systems and Computerized Maintenance Management System (CMMS) program(s).
- Learn to interpret various engineering drawing types such as architectural, electrical, mechanical, piping and instrumentation diagrams (P&ID’s), process / material flow, etc.
- Gain experience in regards to verbal and written communication skills with multi-level audiences.
- Knowledge gained in regards to supporting investigations and SOP’s
- Demonstrate ability to develop and maintain clear and accurate documentation for project management
EDUCATION, EXPERIENCE & SKILLS:
- Currently enrolled students that are registered with a CO based College/University that will be attending the 2023 fall semester in pursuit of a BS in Engineering (Civil, Chemical, Biotechnology, Mechanical, Electrical, or relevant discipline)
- The candidate will be expected to work in a scientific, manufacturing and engineering environment while complying with all safety rules and regulations.
- PC skills including Microsoft Office
- Able to communicate in both verbal and written forms
- Self-starter with a high degree of energy
- Legal authorization to work in the United States - Sponsorship for this role will not be provided
$18 - $22 hourly - 40 Hour Work Week
Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.
Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.
Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company’s performance and the Team Member’s performance.
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.