Full-time

Asahi Kasei•Fremont, CA

11d•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. As part of the MSAT group, the role offers opportunities to specialize in upstream cell culture and/or downstream purification. The position works with multiple functional teams to coordinate GMP manufacturing readiness, technology transfer, and successful completion of client manufacturing projects. Depending on experience, the engineer coordinates or manages GMP manufacturing readiness and technology transfer tasks for client new product introductions. The work includes ensuring readiness of raw materials, documents, equipment, processes, and facilities; supporting process transfer using single-use equipment; troubleshooting equipment and supporting quality activities; and authoring or reviewing technical and manufacturing documents. The role also includes leading internal meetings, maintaining training compliance, training others after trainer qualification, documenting work according to cGMP and cGDP, and undertaking projects to improve workstreams and systems. The position is based in Fremont, California, and requires working in a lab/office setting. The base compensation range is $45–$65 per hour.

Requirements

BS, MS, or PhD in Engineering, Life Sciences, or a related discipline, with 3–5 years of relevant experience for Engineer I or 5–10 years for Senior Engineer; a combination of experience and a relevant advanced degree may also qualify.
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 as it applies 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 think creatively and 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.

Nice To Haves

Relevant experience preferably in a biopharmaceutical manufacturing role.

Responsibilities

Coordinate or manage GMP manufacturing readiness and technology transfer tasks for client new product introduction projects.
Work with Bionova 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 the technology transfer process with internal process development teams, vendors, and clients.
Support technology transfer of processes using single-use equipment, including bioreactors, chromatography, depth filtration, VD, and/or TFF.
Troubleshoot upstream or downstream equipment and support authoring 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 adhere to site regulations and established cGMP requirements.