Engineering Co-Op, Project Engineer (GMP)

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Job description

Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio!

AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics.

The AmplifyBio ecosystem is comprised of three distinct business units: ADOC (South San Francisco, CA)- Amplify's Discovery, Optimization, and Characterization laboratories: ASET (West Jefferson, OH) - Amplify's Safety, Efficacy, and Toxicology Site; and the most recently opened AMEC (New Albany, OH) - Amplify's Manufacturing Enablement Center.

About AMEC New Albany, OH: AmplifyBio's Manufacturing Enablement Center provides customizable cGMP suites to enable advanced therapy manufacturing in a "hoteling model," traditional contract development and manufacturing (CDMO) or a hybrid model. Partnering with AmplifyBio for manufacturing cell therapy, gene therapy, mRNA, plasmid, or other modality is quite different from a typical CDMO experience. The goal is to provide flexible solutions customized to client needs while bringing full expert partnership. At AmplifyBio drug developers will find an innovation-rich ecosystem designed to advance a diverse range and class of pharmaceutical products across development stages.

AmplifyBio is seeking to hire a Engineering Co-Op, Project Engineer (GMP) to join our growing team

The Engineering Co-Op (Project Engineer)'s 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 You'll Do Here:

• Act as a liaison between Engineering / Maintenance, Manufacturing , MSAT 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 & Experience 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 and / or Microbial manufacturing space design and construction.
• Gain knowledge of process transfer and scale up methodology for multi modality 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.

We Would Love to Hear from You If:

• Pursuit of BS in Engineering (Civil, Chemical, Biotechnology, Mechanical, Electrical, or relevant discipline).

At AmplifyBio, we're committed to growing and empowering an inclusive community within our company and industry. Therefore, we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization.

AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.

When you join our team, you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians, and specialists across a variety of disciplines. The future for AmplifyBio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees.

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