Manufacturing Science & Technology Engineer (MSAT)

About the role

The Engineer/Sr. Engineer in Manufacturing Science and Technology (MSAT) will support manufacturing and technology transfer projects at Bionova Scientific’s Fremont facility. The role focuses on upstream cell‑culture and/or downstream purification processes within a GMP environment.

Key responsibilities

• Coordinate and manage GMP manufacturing readiness and tech‑transfer activities for new product introductions.
• Generate and maintain GMP material bills of materials using the ERP system (e.g., QAD).
• Support tech‑transfer of single‑use equipment such as bioreactors, chromatography columns, depth and viral filtration, and TFF.
• Troubleshoot upstream or downstream equipment, author deviations, CAPA reports, and change controls.
• Author and review technical documents, batch records, SOPs, and training materials.
• Analyze key performance indicators to assess process performance and drive improvements.

Required profile

• Bachelor’s, Master’s or PhD in Engineering, Life Sciences or related field with 3‑10 years of biopharma manufacturing experience.
• Hands‑on experience in a GMP facility operating upstream fermentation (single‑use bioreactor) or downstream purification (chromatography).
• Experience with process development, characterization and technology transfer.
• Working knowledge of cGMP compliance and related documentation practices.
• Familiarity with process monitoring software (UNICORN, Pi Historian) and ERP systems (QAD preferred).

Required skills

• Upstream cell‑culture and downstream purification expertise.
• Operation of single‑use bioreactors, chromatography, depth filtration, viral filtration and TFF.
• Process monitoring tools such as UNICORN and Pi Historian.
• ERP system usage, preferably QAD.
• cGMP documentation and compliance.

What we offer

• Medical, dental and vision benefits.
• 401(k) match up to 8% total contribution.
• Paid time off and annual bonus eligibility.
• Base salary range $122,000‑$155,000.