The Position
Filling of insulin & media preparations under aseptic conditions and operation of inspection equipment to achieve production goals.
Reports to Shift Manager.
Essential Functions
- Operate, monitor, and control equipment, systems, and processes associated with Vial/Cartridge filling
- Achieve production goals
- Maintain aseptic areas; perform sanitizations and environmental monitoring
- Participate actively in and support event response
- Review documents as required
- Assist during equipment maintenance (including restoration of lost function; predictive and preventative maintenance)
- Record/review production data in BPRs and associated forms
- Follow all safety and environmental requirements
- Other accountabilities, as assigned
Physical Requirements
- Moves equipment/supplies up to 33 pounds within the facility
- On feet up to a 12-hour shift; routinely operates/inspects equipment using hands
- May require corrected vision (20/20 or 20/25) and color vision; may require latex gloves
- Occasionally ascends/descends a ladder; may work at elevated heights; may work around odorous/hazardous materials; may work in extremely cold environments; may inspect in confined spaces
- Ability to work in loud noise environments with hearing protection; may require motorized vehicle license/operation
Qualifications
- High School Diploma or equivalent (required)
- Minimum 6 months manufacturing experience (required); may be waived with military experience, a BioWorks/BioBlend certification or equivalent, or current Novo Nordisk contractor with 3 months demonstrated performance in the relevant area
- Experience in an FDA regulated environment (preferred)
- Aseptic processing experience (preferred)
- Ability to read/write/understand complicated product documentation and SOPs with attention to detail (required)
- Computer literacy (preferred)
Benefits (as listed)
- Leading pay and annual performance bonus; paid time off with 14 paid holidays
- Health, dental, and vision insurance effective day one
- Guaranteed 8% 401K contribution plus company match option
- 14 weeks paid parental and 6 weeks paid family medical leave
- Tuition Assistance; Life & Disability Insurance; Employee Referral Awards