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Project Engineer
2 months ago
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.
Job SummaryWe are seeking a highly motivated and detail-oriented Project Engineer to join our team at AmplifyBio. As a Project Engineer, you will play a critical role in supporting the management and execution of all project-related activities carried out within the scope of the Engineering CAPEX Plan.
Key Responsibilities- 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 are 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.
- 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.