Project Engineer I

Job Title: Project Engineer I

Location: Fremont, CA

Hours/Schedule: Mon- Fri 8am- 5pm

Compensation: $35.00-$45.25

Type: Contract

Responsibilities

The Plant Engineer will provide Engineering support to the daily operations, continuous improvement, and projects for Drug Substance Manufacturing in a GMP regulated environment.
The resource will abide by the company's Standard Operating Procedures (SOPs) and GMP regulations for the Engineering support provided.
The resource will plan and accomplish goals with guidance from company's internal resources.
Primary responsibilities are equipment ownership and front-line equipment troubleshooting.

Tasks include:

• Fielding escalations from and providing direction to Maintenance/ Automation/Instrumentation
• Troubleshooting down equipment and providing/leading a return-to-service plan
• Coordinating vendor repairs
• Maintenance strategy recommendations
• Spare parts inventory review
• Post-maintenance equipment testing
• Part upgrade recommendations (like-for-like assessments)
• Deviation investigation SME participant
• CAPA ownership
• Engineering assessments and feedback to Process/Automation Engineering
• Work order review.

Requirements

• Technical depth of biopharma processes and equipment, i.e. upstream cell culture, downstream purification, cleaning-in-place, and freezing operations
• Interpersonal skills to work closely with Maintenance/Instrumentation/Automation/Engineering groups.
• Understanding of process controls
• Bachelor's degree in science or engineering, plus 4-10 years of relevant work experience

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.