Aseptic Technician - Filling, Lyophilization, Capping 3rd Shift

Benefits

• $500 Sign on Bonus
• 4 weeks accrued paid vacation and 13 paid holidays.
• 401(k) match with company profit sharing.
• Tuition reimbursement and Student Loan repayment program.
• Great Health, personal, and family benefits starting day 1.

• Assist with aseptic filling, lyophilization and capping procedures.
• Monitor processes and report unusual circumstances and events.
• Assist with mechanical set up procedures in an aseptic environment.
• Use scale, pipettes, calculators and other scientific measuring devices to establish and verify fill volumes, check specific gravity, etc.
• Perform routine environmental monitoring.
• Learn and apply USDA and APHIS requirements to assembly operations.
• Document processes accurately and completely in accordance with SOPs and GMPs.
• Hours:
  
  3rd Shift, Sunday - Thursday 10:00pm - 6:30am. Overtime, weekend, and holidays may be required.

• Handle movement of sterile equipment using practices designed to achieve and ensure equipment sterility.
• Learn and demonstrate understanding of basic sterilization principles and aseptic technique.
• Understand and use fill schedule to meet customers' requirements.
• Basic knowledge and use of inventory management system.
• Basic understanding of RFT Methodologies.
• Assist with operation of CIP/SIP systems, as applicable.
• Basic understanding of the SCADA/EWI system as applicable.
• Assist with Lab Cleaning practices.
• Identify and communicate work order issues.
• Operate fill suites independently.
• Operate capping equipment independently.
• Independently perform mechanical set up procedures in an aseptic environment.
• Assist in updating batch records, SOPs and JTCs.
• Participate in cross training within manufacturing.
• Perform basic repairs, maintenance, disassembly and reassembly of major equipment.
• Identify quality issues.

• High School graduate or equivalent required.
• Demonstrate basic mechanical skills.
• Demonstration of personal computer usage.

• Read, interpret, and apply safety procedures, standard operating procedures, maintenance instructions, and departmental procedures.
• Communicate effectively with peers and Team Leader.
• Document steps accurately and legibly.

• Add, subtract, multiply, and divide in all units of measure.
• Perform conversions within the metric system.
• Complete controlled documents and inventory calculations using basic math.
• Ability to set up and use basic weight devices in standard and metric format.

• Understand and apply instructions in written, oral, and/or diagram formats.
• Multitask.
• Identify product quality issues based on company guidelines, policies, and procedures.
• Working knowledge of Good Manufacturing Practices.

• Demonstrates the ability to work in a team environment.
• Expresses a positive attitude.
• Shows respect for co-workers.

• Manual dexterity using hands and fingers.
• Constant standing for extended periods.
• Frequent need to sit, kneel, crouch, and climb; reach with hands and arms.
• Capable of lifting up to 50 pounds.
• Ability to work flexible hours including work weekend, holiday, and overtime.

• High noise levels;
  Hearing Protection as required.
• Frequent exposure to heavy items; ANSI 75 Safety shoes required.
• Exposure to cleaning agents/chemicals; PPE as required.
• Exposure to moving mechanical parts; ensure safety shields are always in place.
• Exposure to extreme temperature variations; PPE as required.