MSAT Engineer / Senior — Biopharma Tech Transfer

Bionova Scientific LLC; Fremont (CA); On-site; USD 62,000 - 90,000; Full time

Job summary

Bionova Scientific LLC in Fremont, CA, is seeking an Engineer I or Senior Engineer for Manufacturing Science and Technology (MSAT). You will contribute to GMP manufacturing readiness, tech transfer, and client projects, focusing on Upstream cell culture and/or Downstream purification, while coordinating with cross-functional teams at the Fremont site.

The role requires 3–10 years of relevant GMP experience, strong documentation practice, and proficiency with ERP and process monitoring tools.

Qualifications

• BS, MS, or PhD in Engineering, Life Sciences, or related discipline with 3-5 years (Engineer 1) and 5-10 years (Sr. Engineer) of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.
• Hands-on experience working in a GMP manufacturing facility with either upstream fermentation equipment or downstream purification equipment.
• Experience with process development, process characterization and/or tech. transfer processes.
• Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing.
• Experience with process monitoring software and equipment software (e.g. UNICORN, Pi Historian).
• Experience with ERP systems (QAD).
• Creative thinker that can identify better and more efficient methods to address issues and gaps.
• Demonstrate ability to work independently, organize, and communicate effectively.
• Ability to prioritize assignments and to manage multiple projects simultaneously.

Responsibilities

• Coordinate GMP manufacturing readiness and tech transfer tasks as part of new product introduction (NPI) for client projects with cross-functional teams.
• Generate and maintain GMP material bill of materials (BOM) using ERP system (QAD).
• Ensure facility fit and tech transfer with internal process development teams, vendors, and clients.
• Support tech transfer of processes using single-use equipment including bioreactor, chromatography, depth filtration, VD and/or TFF.
• Support US or DS equipment troubleshooting, deviations, CAPA, and change controls.
• Author and review technical documents such as reports, experimental plans, production batch records, training materials, and manufacturing SOPs per project needs.
• Lead internal meetings and communicate effectively with internal stakeholders.
• Contributes to quality activities such as investigations, authoring deviations, CAPAs, and Change Controls.
• Documents work according to cGMP and cGDP; adheres to site regulations.

Skills

GMP manufacturing

Process development

Tech transfer

Independent work

Education

BS, MS, or PhD in Engineering/Life Sciences

Tools

UNICORN

Pi Historian

QAD ERP

Job description

Bionova Scientific LLC in Fremont, CA, is seeking an Engineer I or Senior Engineer for Manufacturing Science and Technology (MSAT). You will contribute to GMP manufacturing readiness, tech transfer, and client projects, focusing on Upstream cell culture and/or Downstream purification, while coordinating with cross-functional teams at the Fremont site.

The role requires 3–10 years of relevant GMP experience, strong documentation practice, and proficiency with ERP and process monitoring tools.