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Egg White Harvest Technician II Holden United States,
Posted on : 07 June 2017
- The Egg White Harvest Technician II (EWH Technician II) will perform all daily EWH activities including harvests, environmental monitoring, sampling, line clearances, and documentation; follow standard operating procedures and good documentation practices; organize, clean, and maintain harvest suite, supplies, and equipment.
- The EWH Technician II will support the production facility by working shifts, weekends, and holidays as needed.
- Egg white harvest according to established Standard Operational Procedures (SOP s) in accordance with current Good Manufacturing Practices (cGMP).
- Execution of Master Batch Records (MBR s) in accordance with Good Documentation Practices (GDP).
- Aseptic manipulations within a laminar flow hood according to established Standard Operating Procedures (SOP s).
- Equipment operation (EM and manufacturing)
- Inventory control
- Accountability to individual and team safety policies and procedures.
- Completion of cGMP documentation according to approved procedures
- Process sampling
- Ability to withstand -20C temperature exposure
- Cleaning and sanitization of equipment
- General housekeeping of laboratory area
- Leads EW shipping and the receiving of EWH materials
- Performs hands on training for new EWH technicians
- Maintains EWH and EM databases
- Revises EWH procedures and forms
- Provides first drafts of Deviations, OOS, or CAPAs for EWH activities.
- Leads team in absence of Supervisor/lead
- Excellent verbal and written communication skills.
- Experience with inventory control methods and electronic inventory systems preferred.
- Proficiency in Outlook, Word and Excel and knowledge of PC spreadsheets required.
- Experience in a manufacturing environment is a plus.
- High School Diploma plus 3-5 years experience in cleanroom or GMP environment
- BS, AS, or Certificate plus 1-2 years experience in cleanroom or GMP environment
- Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Our company developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders.
- As the global leader in complement inhibition, our company is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders.
- Our company's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders
- In addition, our company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas
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