MSAT Engineer | GMP Tech Transfer & Biopharma Manufacturing

Asahi Kasei Bioprocess America, Inc.

Fremont (CA)

On-site

USD 62,000 - 90,000

Full time

7 days ago

Be an early applicant

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Job summary

Bionova Scientific LLC in Fremont, CA seeks an MSAT Engineer/Sr. Engineer to advance GMP manufacturing readiness and technology transfer for biopharma projects. The role emphasizes collaboration across functional teams and effective documentation within cGMP frameworks.

Required are 3–5 years (Engineer 1) or 5–10 years (Sr. Engineer) in GMP biopharma, with experience in upstream/downstream equipment, tech transfer, and ERP systems like QAD. On-site position with competitive compensation.

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 in a GMP manufacturing facility with upstream fermentation equipment (e.g. single-use bioreactor) or downstream purification equipment (e.g. chromatography).
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.
Generate and maintain GMP material BOM; use ERP systems (QAD).
Ensure facility fit and tech transfer with internal process development teams, vendors, and clients.
Support tech transfer of processes using single-use equipment (bioreactor, chromatography, depth filtration, VD and/or TFF).
Support US or DS equipment troubleshooting, deviations, CAPAs, and change controls.
Author/review technical documents: reports, plans, batch records, training materials, SOPs.
Lead internal meetings and communicate with stakeholders.
Contribute to investigations, deviations, CAPAs, and Change Controls.
Maintain training and train others; document work per cGMP/cGDP.