Aseptic Technician - Evening Shift

General Summary and Purpose

The Aseptic Technician I is a core team member of the manufacturing team. The Aseptic Technician I is responsible for daily production including environmental monitoring, formulating, and filling of aseptic GMP manufactured products according to batch records and SOPs. This entry position allows for exposure to many department’s ways of working and opportunities for cross functional projects. Allows for insight into the world of biotechnology.

• 90-95% of job duties will be directly related to routine processes of bulk formulation, filling, and packaging of Quality System regulated compliant media products. This includes but is not limited to:
  • Disinfecting and transferring materials and equipment into the cleanroom for production.
  • Working inside cleanroom suites on your feet for several hours at a time.
  • Perform environmental monitoring.
  • Weighing, measuring, and checking raw materials to ensure batches manufactured contain proper ingredients and quantities.
  • Aseptically fill solutions into finished product containers under sterile conditions.
  • Perform washing of labware used in GMP manufacture.
  • Perform cleaning of equipment and classified clean rooms facility (ceiling, walls, critical surfaces, and floors).
  • Performing repetitive tasks while gowned (hood, mask, coveralls, boots, gloves, etc.).
  • Operate equipment such as balances, volumetric glassware, peristaltic pumps, filters, pH meter, and pipettes.
  • Perform all tasks while following all SOPs, batch records, and safety policies.
  • Accurately complete batch record documentation, all appropriate logbook entries, and GMP documentation.
• 5-10% of job duties will include indirect manufacturing support projects. This includes but is not limited to:
  • Perform preventive maintenance on manufacturing equipment.
  • Perform root cause investigations for Quality issues.
  • Perform batch record and SOP revisions.
  • Proposes champions and implements process improvements.
  • Real time review of production records (GDP) ensuring operators are documenting procedures in real time.
  • Other projects and duties as required.
• May be required to work either day or evening shift as needed.
• May occasionally be required to work weekends and overtime as needed.
• Required to be on-call for equipment monitoring on a rotation.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

This position reports to the Manager, Manufacturing.

• Bachelor’s degree; or Associate degree / Biotech cert and 1 year of relevant experience; or High school diploma / GED and 2 years of relevant experience.
• Self-motivated and willing to accept temporary responsibilities outside of normal job duties.
• Comfortable working in a fast-changing small company environment and able to adjust workload based on changing priorities.
• Must not have unusual sensitivity to typical laboratory chemicals (i.e., sanitization agents).
• Must be able to perform fast paced operations and repeatedly perform multi-step simultaneous operations with a high degree of accuracy.
• Effectively communicate while wearing cleanroom gowning (mask, hood, coveralls, gloves, etc.).
• Must be able to work effectively in a group and independently.
• Must be able to meet aseptic gowning qualification requirements.
• Must be able to work regularly with cleaners.
• Must be able to lift up to 50 lbs. and push/pull up to 1200 lbs. with assistance.

• Familiarity with aseptic processing in a cGMP/FDA regulated environment.
• Prior cleanroom gowning experience.
• Familiarity with Lean/Six Sigma/5S.
• Degree in sciences with an interest in pharmaceutical manufacturing.
• Familiarity with Microsoft Office programs (Word, Excel, Outlook).
• May be required to work either day or evening shift.
• May occasionally be required to work weekends and overtime.

This opening is for the Evening Shift from 12 PM–8:30 PM and includes a shift premium.

US base salary…