Senior Biopharma MSAT Engineer - GMP & Tech Transfer

Bionova Scientific LLC; Fremont (CA); On-site; USD 122,000 - 155,000; Full time

Benefits offered by this job

Direct Hire

Medical, Dental, Vision

401K (match up to 5%, plus an extra 3%

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) to support manufacturing and technology transfer projects.

You will specialize in Upstream Cell Culture and/or Downstream Purification, coordinate GMP readiness activities, prepare documents, and work with cross-functional teams. This role offers direct hire status and a competitive package with benefits.

Qualifications

• BS, MS, or PhD in Engineering, Life Sciences, or related discipline.
• 3-5 years (Engineer 1) and 5-10 years (Sr. Engineer) of relevant experience in biopharma manufacturing.

Responsibilities

• Coordinate GMP manufacturing readiness and tech transfer tasks for client projects.
• Work with internal teams to ensure readiness of materials, documents, equipment, processes and facilities.
• Generate and maintain GMP material BOM and related documentation.
• Support tech transfer using single-use equipment (bioreactors, chromatography, filtration).
• Author and review technical documents (reports, batch records, SOPs).
• Maintain compliance with cGMP/cGDP and participate in investigations and CAPA.

Skills

GMP manufacturing

Upstream/Downstream

Process development

Tech transfer

ERP systems (QAD)

Process monitoring software

UNICORN

Pi Historian

Creative thinking

Independent work

Project prioritization

Education

BS/MS/PhD in Engineering or Life Sciences

Tools

QAD

UNICORN

Pi Historian

Job description

Bionova Scientific LLC in Fremont, CA, is seeking an Engineer/Sr. Engineer in Manufacturing Science and Technology (MSAT) to support manufacturing and technology transfer projects.

You will specialize in Upstream Cell Culture and/or Downstream Purification, coordinate GMP readiness activities, prepare documents, and work with cross-functional teams. This role offers direct hire status and a competitive package with benefits.