Senior MSAT Engineer, Biomanufacturing & Tech Transfer

Asahi Kasei Bioprocess America, Inc.

Fremont (CA)

On-site

USD 122,000 - 155,000

Full time

14 days+

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Benefits offered by this job

Medical insurance

Dental

Vision

401K

Paid time off

Annual bonus eligible

Job summary

Bionova Scientific LLC in Fremont, CA is seeking an Engineer/Sr. Engineer in Manufacturing Science and Technology (MSAT).

You will contribute to manufacturing and technology transfer projects, specializing in Upstream Cell Culture and Downstream Purification, and coordinate readiness activities across GMP operations. The role requires hands-on GMP experience with single-use bioreactors or purification equipment; strong collaboration with cross-functional teams; and documentation of deviations,

Qualifications

BS/MS/PhD in Engineering or Life Sciences.
3–5 years (Engineer 1) and 5–10 years (Sr. Engineer) of relevant experience in biopharma manufacturing.
Hands-on GMP manufacturing experience with upstream or downstream equipment.
Experience with process development, characterization and tech transfer.
Familiarity with ERP and process monitoring software (QAD, Unicorn, Pi Historian).

Responsibilities

Coordinate GMP manufacturing readiness and tech transfer tasks for new product introductions.
Ensure readiness of raw materials, documents, equipment and facilities.
Generate and maintain GMP BOM; use ERP system (QAD).
Support tech transfer with single-use equipment (bioreactor, chromatography, depth filtration, viral filtration, TFF).
Author deviations, CAPAs and change controls; document manufacturing activities.
Lead internal meetings and communicate with stakeholders; train teammates as needed.
Document work according to cGMP and cGDP; adhere to site regulations.