The Aseptic Automation Technician will operate automated manufacturing equipment used to create products with a focus on patient safety and quality; they will ensure that equipment is operating appropriately to meet manufacturing demand.
- Responsible for the operation and maintenance of automated filling equipment.
- Performs setup, teardown, and cleaning of automated equipment.
- Maintains cleanroom conditions, by gowning, sanitation, and behaving according to procedures that align with cGMP practices or guidelines.
- Ensures that assigned equipment validation activities are up to date.
- Help assess performance of equipment and aid in trouble shooting for any challenges that arise.
- Takes inventory to identify components needed to fulfil production batches, as scheduled.
- Coordinates and communicates with compounding and dispensing to obtain supplies needed to turn products; communicates with both the aseptic and post-production teams.
- Document batch records, lumacs (log use, maintenance, and cleaning of all equipment), and cleaning logs appropriately.
- Ensures that gowning standards have been maintained on a semi-annual basis.
- Performs initial and routine qualifications for equipment, including media fills, if required.
- Follows standard operation procedures for the completion of assigned tasks.
- Clock in and out for each scheduled shift in a timely manner.
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Set Yourself Apart: Profile/Experiences
- High school diploma or equivalent; one to four years previous work experience in a hospital, manufacturing production environment, or aseptic filling.
- Experience with automated equipment or automated manufacturing lines preferred.
- Knowledge of and compliance with cGMP (Current Good Manufacturing Practices) regulations, preferred.
- Ability to aseptically gown and pass gowning qualifications.
- Ability to work with others in a positive and professional manger and to develop and maintain strong working relationship with co-workers and management.
- Ability to take initiative, including asking for and offering help when needed; performs work independently without being prompted.
- Strong attention to detail and focus on quality, accuracy, sterility, and aseptic technique.
- Ability to prioritize and plan work activities. Manages time effectively and adapts quickly to changing priorities.
- Ability to handle multiple tasks and organize resources to ensure work is completed on time.
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.