
Scientist – Microbiology Team Technician
- Lincoln, NE
- Permanent
- Full-time
- Ensure compliance of Environmental monitoring program with the Annex 1.
- Complete and review Monthly, Quarterly, and Semi-annual EM reports.
- Complete high-level investigations of the EM and Media prep area.
- Review and approve EM investigation of action and alert levels in the production areas.
- Assist in the development of new EM and water testing programs and redevelopment of existing programs.
- Prepare aseptic and non-aseptic media for other groups within QO.
- Perform Environmental Monitoring in production areas.
- Perform Water Testing of production areas.
- Perform Endotoxin testing on water samples.
- Monitor processes and alert supervisory personnel of known or suspected quality problems.
- Practice basic aseptic laboratory procedures as per training and SOPs (Standard Operating Procedures)
- Apply (GLP) and Good Manufacturing Practices (GMP) to assigned work.
- Learn and comply with regulatory requirements such as USDA, FDA, EU
- Assist in inventory management of laboratory supplies, assist in the equipment preparation and sterilization for laboratories as needed.
- Routine glassware and apparatus preparation, washing of glassware.
- Decontaminate materials from laboratories via autoclave sterilization.
- Sterilize glassware and other materials for use in laboratories.
- Pickup and delivery of laboratory equipment and glassware for cleaning and sterilization based on several communication channels and schedules.
- Two years associate degree in science or
- one to three years relevant experience with relevant science-based college courses or
- Three to five years of experience in a biological manufacturing setting
- Bachelor’s degree in biological sciences/chemistry
- Experience with aseptic manufacturing environments.
- Thorough understanding of the principles of Environmental Monitoring.
- Knowledge of EM regulatory requirements.
- Ability to make logical decisions concerning assay results.
- Competent using Window-based applications, specifically MODA, SAP, LIMS, Process Runner, and Excel
- Experience with aseptic manufacturing environments.
- Knowledge of EU Annex 1 and ISO requirements.
- Exception Organization, Communication, and Interpersonal skills.
- Ability to lift 20-50 pounds routinely, withstand long periods of standing, exposure to temperature. Manual dexterity using hands and fingers.
- Withstand long periods of standing.
- Exposure to high temperatures (autoclaves)Occasional need to sit, reach with hands and arms.
- Manual dexterity using hands and fingers.
- Specific vision abilities required by this job include close vision work.
- Occasional need to sit, reach with hands and arms.
- Ability to work flexible hours, work weekend and overtime