Process Engineer Associate
6 days ago
We are seeking a highly skilled Process Engineer Associate to join our team at BioSpace, Inc. This is an exciting opportunity to work with a talented group of professionals who are passionate about delivering high-quality products and services.
The successful candidate will be responsible for ensuring the successful ramp-up of process tracks, providing input and review of design and requirement documents, and ensuring the quality of equipment and processes.
Key Responsibilities- Provide input, review, and approve design and requirement documents
- Ensure the quality of equipment and processes
- Support the creation of process tracks risk assessment documents, such as Requirement Risk Assessments (RRA's)
- Participate in the creation of a project cGMP Statement
- Creation and participation in QRM risk assessments, such as Closed-Process, Cross-Contamination, Contamination, and Facility flows
- Input and review of Process FMECA's for the Process tracks
- Participation in design work shops with engineering suppliers
- Input and review of Process Module Diagrams, and Process Flow Diagrams
- Input and review of Process Scheduling and Capacity Calculations
- Support package in maintaining schedule adherence
- Ensure coordination and collaboration between project and other site stakeholders
- Gathering and ensure knowledge transfer to project from DK sponsor site
The ideal candidate will have a Bachelor's degree in science or engineering, preferably in Mechanical, Electrical, Chemical, or Industrial, or an equivalent combination of education and related experience in a GMP environment for more than five years.
Minimum of one year of work-related engineering experience in Manufacturing, Design, Maintenance, or Process Improvement is preferred.
What We OfferWe offer a competitive salary and benefits package, including leading pay and annual performance bonus for all positions, generous paid time off, health insurance, dental insurance, vision insurance, guaranteed 8% 401K contribution, and individual company match option.
We are committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve, and the communities we operate in.
At BioSpace, Inc., we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world.
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