Senior MSAT Engineer – GMP Biopharma Process Transfer

Bionova Scientific, Inc.

Fremont (CA)

On-site

USD 122,000 - 155,000

Full time

4 hours ago

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Benefits offered by this job

Direct Hire

Medical, Dental, Vision, 401K match up

Annual Bonus eligible

Job summary

Bionova Scientific LLC in Fremont, CA is seeking an Engineer/Sr. Engineer for Manufacturing Science and Technology (MSAT) to advance GMP manufacturing readiness and tech transfer for upstream/downstream projects.

You will collaborate with cross-functional teams to enable successful client projects and maintain cGMP documentation. The role involves coordinating processes, reviewing reports, and supporting equipment transfers.

Qualifications

BS, MS, or PhD in Engineering, Life Sciences, or related discipline with 3-5 years (Engineer 1) or 5-10 years (Sr. Engineer) experience.
GMP manufacturing facility experience with upstream or downstream equipment.
Experience with process development, tech transfer, and regulatory compliance.

Responsibilities

Coordinate GMP manufacturing readiness and tech transfer for client projects.
Generate and maintain GMP material BOM and use ERP systems (QAD).
Ensure facility fit and tech transfer with internal teams, vendors, and clients.
Support tech transfer using single-use equipment (bioreactor, chromatography, filtration).
Author and review technical documents and CAPA/change controls as needed.
Analyze KPIs and lead internal meetings with stakeholders.