Engineering Co-Op, Project Engineer (GMP)
Company: AmplifyBio
Location: New Albany
Posted on: October 2, 2024
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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.PI3997ea3be6c2-25660-35627588
Keywords: AmplifyBio, Middletown , Engineering Co-Op, Project Engineer (GMP), Engineering , New Albany, Ohio
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