Full-time

Asahi Kasei•Fremont, CA

13d•$45 - $65•Onsite

About The Position

The Engineer I/Sr. Engineer in Manufacturing Science and Technology (MSAT) will contribute to manufacturing and technology transfer projects at Bionova Scientific’s West Warren Fremont location. The role may specialize in upstream cell culture and/or downstream purification and works with multiple functional teams to coordinate GMP manufacturing readiness, technology transfer, and successful completion of client manufacturing projects. The job is located in Fremont, California. Responsibilities include coordinating or managing GMP manufacturing readiness and new product introduction activities; preparing and maintaining material bills of materials in an ERP system; supporting facility fit and technology transfer; troubleshooting equipment; contributing to quality activities; and authoring and reviewing technical and manufacturing documentation. The position also involves leading internal meetings, improving workstreams and systems, maintaining required training, training others after trainer qualification, and documenting work in compliance with cGMP and cGDP.

Requirements

BS, MS, or PhD in Engineering, Life Sciences, or a related discipline, or a combination of experience and a relevant advanced degree.
Relevant experience: 3–5 years for Engineer I or 5–10 years for Senior Engineer; preferably in biopharmaceutical manufacturing.
Hands-on experience in a GMP manufacturing facility with upstream fermentation equipment, such as a single-use bioreactor, or downstream purification equipment, such as chromatography.
Experience with process development, process characterization, and/or technology transfer.
Working knowledge of cGMP compliance relating to procedures, processes, and manufacturing.
Experience with process monitoring and equipment software, such as UNICORN or Pi Historian.
Experience with ERP systems such as QAD.
Ability to identify more effective methods for addressing issues and gaps.
Ability to work independently, organize work, and communicate effectively.
Ability to prioritize assignments and manage multiple projects simultaneously.
Ability to walk, stand, stoop, kneel, and crouch; occasionally lift or move up to 20 pounds independently.

Responsibilities

Coordinate or manage GMP manufacturing readiness and technology transfer tasks for client projects as part of new product introduction.
Work with functional teams to ensure readiness of raw materials, documents, equipment, processes, and facilities.
Generate and maintain GMP material bills of materials (BOM) using an ERP system such as QAD.
Ensure facility fit and support technology transfer with internal process development teams, vendors, and clients.
Support transfer of processes using single-use equipment, including bioreactors, chromatography, depth filtration, VD, and/or TFF.
Support upstream or downstream equipment troubleshooting and author deviations, corrective actions (CAPA), and change controls.
Author and review technical documents, including reports, experimental plans, production batch records, training materials, and manufacturing SOPs.
Lead internal meetings and communicate with internal stakeholders.
Contribute to quality activities, including investigations, deviations, CAPAs, and change controls.
Execute additional projects and assignments to refine and improve workstreams and systems.
Maintain personal training compliance and train others after completing trainer qualification.
Document work according to cGMP and cGDP and follow established site regulations and cGMP requirements.