Senior Biopharma Process Engineer - Automation & Compliance

Bayside; Fremont (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Bayside in Fremont is seeking a Principal Process Engineer to join their growing team. The role focuses on ensuring process equipment readiness, adapting multi-product facilities, and leading technical projects from planning to startup.

The candidate should have 7+ years in biopharma, an engineering degree, and strong experience in purification, cell culture, and SAP. Expect responsibilities in compliance, quality, and continuous process optimization.

Qualifications

• MS/BS degree in Engineering or related degree with over 7 years of experience in a biopharmaceutical industry.
• Experience with purification and cell culture required.
• Understands technical knowledge of related process steps and associate unit operations.
• Knowledge of manufacturing and process development plants.
• Able to maintain relationships with internal employees and work with outside vendors.
• Experience leading/managing of technical projects with teams from realization to start up.
• Working knowledge of SAP program.
• Engineering skills to design new systems and to also make improvements.
• Good project-management skills, able to manage outside contractors during project execution.

Responsibilities

• Responsible for the process equipment readiness including related automation.
• Multi-product facility and equipment adaptation as customer products enter the facility for the first time.
• Manages leads and motivates project teams by technical competence, interpersonal sensitivity and conflict management skills.
• Manages simple facility and equipment related projects and acts as Engineering lead on facility/equipment projects.
• Ensures that the process equipment, machinery, documentation and technical support meets the compliance, quality and EHS standards.
• Leads BPE/MPE activities to ensure a continuous optimization process.

Skills

Biopharma experience

Project management

Team leadership

SAP knowledge

Education

MS/BS in Engineering or related field

Tools

SAP

Job description

Bayside in Fremont is seeking a Principal Process Engineer to join their growing team. The role focuses on ensuring process equipment readiness, adapting multi-product facilities, and leading technical projects from planning to startup.

The candidate should have 7+ years in biopharma, an engineering degree, and strong experience in purification, cell culture, and SAP. Expect responsibilities in compliance, quality, and continuous process optimization.