POSITION SUMMARY

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.

QUALIFICATIONS

• 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 GMP manufacturing environment required.

EDUCATION

• High School Diploma plus 2 years’ experience in cleanroom or GMP environment
• BS, AS, or Certificate plus 1 years’ experience in cleanroom or GMP environment

• 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 room 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 with appropriate Personal Protective Equipment (PPE)
• Cleaning and sanitization of equipment
• General housekeeping of manufacturing 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