Aseptic Fill Lead Technician

This position will coordinate activities and technicians in aseptic filling and support areas in the production of licensed products and intermediates. Generates schedules for production, formulation and fill and packaging of products. Utilize mechanical skills to maintain equipment and identify mechanical problems. Maintain a safe work environment as well as demonstrate reliability in attendance.

EDUCATION, EXPERIENCE AND TECHNICAL SKILLS:

• Bachelor of Science in Microbiology, Biology, Biochemistry, biochemical engineering, chemical engineering, industrial microbiology, or related degree
• Minimum of 5 years’ experience in a manufacturing environment
• Experience with the manufacture of biological products is required
• Experience in a USDA licensed facility required
• Prior experience with leading projects and mentoring technical staff
• Working knowledge of USDA regulatory requirements
• Must have demonstrated team leadership skills and be able to communicate effectively with people and team members at all levels of the organization
• Self-motivated with a strong work ethic
• Demonstrate reliability in attendance and punctuality
• Knowledge of and ability to operate computer control systems
• Ability to give direction as needed with respect to machine operation
• Assists with diagnosing and trouble-shooting maintenance related issues.
• Comply with Standard Operating Procedures (SOPs) and associated documentation necessary to perform job functions
• Knowledge of proper data capture, such as with Notebooks, or Process Worksheets
• Must be able to read, understand, and execute detailed written instructions
• Must be able to learn and follow site, equipment, and personnel trafficking policies
• Must be able to interact with and express requirements in a positive and professional way to colleagues at all levels within the organization

POSITION RESPONSIBILITIES:

• Lead 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
• Document processes accurately and completely in accordance with SOPs and GMPs
• Leads aseptic fill production team in compliance and quality improvement efforts
• Ensures adequate capacity by scheduling facility and equipment utilization and recommending changes and capital purchases.
• Handle movement of sterile equipment using practices designed to achieve and ensure equipment sterility
• 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
• Analyze current production processes and identify potential improvements
• Must be a self-starter, motivated, and collaborative
• Ensures compliance with all trafficking and housekeeping requirements.
• Ensures compliance with respect to employees, laboratory, and documentation.
• Cleaning and replacement of glassware, solutions preparation, autoclaving and general lab organization
• Assist in general laboratory management including inventory, ordering, and organization
• Assists other laboratory/manufacturing personnel in high volume, multiple-task related activities
• Recording data promptly and accurately
• Implementing task lists as outlined by supervisor or other senior laboratory personnel
• Conducting work in accordance with appropriate company policies and regulatory agencies
• Conducting work in accordance with company safety requirements
• Monitoring of laboratory equipment
• Assists in developing procedures for internal and external customers, including protocol development, SOP development, and personnel training
• Maintaining accurate inventories of raw material, in-process material, and finished goods
• Routinely surveying facility, equipment, and systems, to ensure all areas are in excellent working conditions (organized, clean, safe)
• Assist in training entry-level employees