
Aseptic Technician – Filling, Lyophilization, Capping 2nd Shift 2:00pm – 10:30pm
- Lincoln, NE
- Permanent
- Full-time
- 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 of 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
- 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 customer's 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.
- Utilize Micromax/SCADA system for lyophilizers.
- Operate capping equipment independently.
- Independently perform mechanical set up procedures in an aseptic environment
- Assist in updating of batch records, SOPs and JTC's
- Participate in cross training within manufacturing.
- Participate in special project teams (i.e., Safety, RFT, Kaizen events)
- Perform basic repairs, maintenance, disassembly, and reassembly of major equipment.
- Ability to identify quality issues.
- High School graduate or equivalent required.
- Demonstrate basic mechanical skills.
- Demonstration of personal computer usage
- Demonstrate good communication skills.
- 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
- Ability to recognize product quality issues based on company guidelines, policies, and procedures.
- Working knowledge of Good Manufacturing Practices
- Demonstrates good listening skills.
- Demonstrates the ability to work in a team environment.
- Expresses a positive attitude.
- Shows respect for co-workers.
THE PHYSICAL DEMANDS DESCRIBED HERE ARE REPRESENTATIVE OF THOSE THAT MUST BE MET BY AN EMPLOYEE TO SUCCESSFULLY PERFORM THE PRINCIPLE DUTIES OF THIS JOB. REASONABLE ACCOMMODATIONS MAY BE MADE TO ENABLE INDIVIDUALS WITH DISABILITIES TO PERFORM THE PRINCIPLE DUTIES.
- 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
THE WORK ENVIRONMENT CHARACTERISTICS DESCRIBED HERE ARE REPRESENTATIVE OF THOSE AN EMPLOYEE ENCOUNTERS WHILE PERFORMING PRINCIPLE DUTIES OF THIS JOB. NOTED PERSONNEL PROTECTION EQUIPMENT (PPE) MUST BE UTILIZED WHILE ON THE JOB.
- 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