Senior MSAT Engineer: Biopharma GMP & Tech Transfer

Celgard; Fremont (CA); Sur place; USD 122 000 - 155 000; Plein temps

Avantages offerts par ce poste

Direct Hire

Medical, Dental, Vision (benefits)

401K match up to 5% (plus 3% company)

Paid time off

Annual Bonus eligible

Résumé du poste

Bionova Scientific LLC is seeking an Engineer/Sr. Engineer in Manufacturing Science and Technology (MSAT) at Fremont, CA. You will work across upstream cell culture and downstream purification, coordinating GMP manufacturing readiness, tech transfer, and client projects.

The role requires hands-on GMP experience, collaboration across teams, and involvement in process development, documentation, and change controls. Fremont site offers growth in a dynamic biopharma setting.

Qualifications

• BS, MS, or PhD in Engineering, Life Sciences or related discipline.
• 3–5 years (Engineer 1) or 5–10 years (Sr. Engineer) of relevant experience in biopharma manufacturing.
• Experience with GMP manufacturing and tech transfer processes.

Responsabilités

• Coordinate GMP manufacturing readiness and tech transfer for client projects.
• Generate and maintain GMP material BOM; use ERP systems (QAD).
• Support tech transfer with single-use equipment (bioreactor, chromatography, filtration).
• Assist deviations, CAPAs, and change controls.
• Prepare and review technical documents and SOPs; track KPIs.
• Lead internal meetings and coordinate with stakeholders.

Connaissances

Coordination

Project management

Communication

Independent work

Problem solving

Formation

BS/MS/PhD in Engineering/Life Sciences

Outils

UNICORN

Pi Historian

QAD

Description du poste

Bionova Scientific LLC is seeking an Engineer/Sr. Engineer in Manufacturing Science and Technology (MSAT) at Fremont, CA. You will work across upstream cell culture and downstream purification, coordinating GMP manufacturing readiness, tech transfer, and client projects.

The role requires hands-on GMP experience, collaboration across teams, and involvement in process development, documentation, and change controls. Fremont site offers growth in a dynamic biopharma setting.