Role: Plant Engineer
Location : 800 Dwight Way, Berkeley, CA 94710 - 5 days a week on-site
Hourly Pay Rate: 60/hr to 70/hr
About the Role
The Group seeks an experienced Plant Engineer to partner with the production team in producing cell therapy molecules. Also, helping to consult to troubleshoot process improvement. Looking for someone with a process engineering background, GMP, design, maintenance, and some production experience.
Core Responsibilities
- Provide the necessary technical expertise for troubleshooting and resolving problems with Production Unit equipment/Utilities (e.g. HVAC, CW/WFI, etc.) ; ensure resolution of critical items.
- Perform P&ID walkdowns and redlines as needed
- Perform Risk Assessments and resolution of risk analysis;
- Develop, review, and implement recommendations to improve reliability of infrastructure and production systems.
- Maintain the Calibration, Maintenance and Safety procedures in defined area of responsibility
- Develop specification and strategy of spare parts to meet reliability objectives;
- Support Quality action items and write Engineering Assessments as Subject Matter Expert (SME);
- Coordinate maintenance activities and shutdown requirements for production equipment and facilities
Required Qualifications
- Bachelor of Science Degree in Chemical, Electrical, Mechanical Engineering or related discipline; Bachelor of Science
- Knowledge and hands on experience with pharmaceutical manufacturing processes, including equipment, utilities, and facilities, cGMP compliance, high purity water systems, clean room HVAC systems, process instrumentation and control systems, etc., are required
- Experience with Process Control Systems, including DCS, PLC, instrumentation and low voltage electrical systems; Experience with FAT, SAT, Commissioning and Qualification, including hands on experience starting up and running new equipment, resolving technical equipment issues, developing turn over packages;
- Demonstrated ability to troubleshoot complex equipment / systems and supporting utility services; Ability to troubleshoot equipment failures immediately and communicate status to engineers and production
- Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments; Flexibility to support business requirement of rotational on call support and / or weekend coverage.