Job Title: Plant Engineer
Location: Fremont CA 94555
Duration: 3 months
Functional Area: Engineering/Site Services
Duties:
- 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 Client Standard Operating Procedures (SOPs) and GMP regulations for the Engineering support provided.
- The resource will plan and accomplish goals with guidance from BI 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.
Skills:
- 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
Physical demands:
- Ability to lift 50lbs with assistance.
Education:
- Bachelor’s degree in science or engineering, plus 4-10 years of relevant work experience
You can reach me at yeshwant.gattem@compunnel.com or call me at +1-609-779-2682.
Thanks,
Yeshwant Gattem
Recruiter
+1-609-779-2682
