Mitchell Doke
Engineer Energy/FAC/GMP Lead - Biologics Production Facility Transplant - Nebraska Medicine
- Role
- Energy Fac Engineer Lead - Biologics Production Facility at Nebraska Medicine
- Location
- Omaha, NE, US
- LinkedIn followers
- 500 followers
About Mitchell Doke
Engineering, Management, Technical, Leadership, Team Building, Motivation, Sales…
Experience
Energy Fac Engineer Lead - Biologics Production Facility
Aug 2010 — Present · Omaha, NE, US
NEBRASKA MEDICINEBIOLOGICS PRODUCTION FACILITY, BPF Engineer GMP, Energy/FAC Systems Omaha, Nebraska, 2010 to CurrentDedicated to human cellular/tissue based production of products for the treatment of cancer and other diseases. The BPF is also a regional center serving the NMDP, National Marrow Donor Transplant Program. Duties include designing, writing up and executing validation protocols, CCRs, change control requests, SOPs, Standard Operational Procedures and OR’s Occurrence Reports relating to equipment and procedures. Prepare organized record/document structures of procedures, preventative maintenance records, improvements and service activities and preparation for FDA/GMP/FAC compliance and audits. Report to Operations Manager. Work closely with Lead Lab supervisor and all other lab technicians. Coordinate compliance issues with Manager of Regulatory Affairs with GMP, Good manufacturing Practices, the FDA, Food and Drug Administration and FAC.Responsibilities include engineering, management, technical commissioning, coordinate projects, mission critical modifications, ongoing preventative maintenance, service and energy management. Ensure excellent clean room laboratory environments for cellular therapy operations. Manager and point of contact for personnel, facility projects pertaining to HVAC, plumbing, refrigeration, electronics, temperature controls and electrical systems. Coordinate with University NE. Medical Center personnel, all inside/outside architects, engineers and contractors.
Education
Clarkson College
Master’s of Science MS
Bellevue University
Bachelors of Science BS
2001
Des Moines Area Community College
Associates of Applied Science AAS
Drake University
Computer Programming and Arts
Skills
- Sales Operations
- Customer Satisfaction
- Business Process Improvement
- Healthcare
- Electricians
- Sales
- Project Management
- Leadership
- Engineering
- Contract Negotiation
- Process Improvement
- Hvac
- Troubleshooting
- Electronics
- Internal Controls
- Sales Management
- Management
- Team Building
- Construction
- Change Management
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