21 час назад
API Manufacturing Associate I
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
API Manufacturing Associate I (Pharmaceutical Manufacturing): Operating highly automated API manufacturing equipment and processes to meet production goals with an accent on GMP compliance, batch record review, and safe material handling. Focus on troubleshooting equipment, supporting qualification and validation activities, maintaining clean rooms, and executing production schedules.
Location: Onsite at API manufacturing facilities in Lexington and Clayton, North Carolina, United States
Company
presents an opportunity with Novo Nordisk, a pharmaceutical manufacturer producing injectable and oral treatments at multiple North Carolina facilities.
What you will do
- Operate, monitor, and control highly automated API manufacturing processes and equipment.
- Execute production schedules and handle products from trucks, tankers, and ISO containers.
- Review electronic batch records and manufacturing documentation for compliance with SOPs and cGMP standards.
- Participate in qualification, validation, troubleshooting, equipment maintenance, and restoration of lost function.
- Maintain clean room areas and perform environmental monitoring when required.
- Follow safe and environmentally responsible work practices and manage an individual training plan.
Requirements
- High school diploma or equivalent required; an associate degree or higher in technology, science, or engineering is preferred.
- Computer literacy, including operation of computer-driven manufacturing equipment and Microsoft Office, required.
- Ability to read and understand complex product documentation and SOPs with strong attention to detail.
- Ability to perform basic material handling safely and use material handling equipment effectively.
- General knowledge of cGMP manufacturing and pharmaceutical production processes required.
- Ability to work up to 12-hour shifts on foot and around noise, hazardous materials, confined spaces, elevated heights, and cold environments when required.
Nice to have
- At least two years of manufacturing experience in an FDA-regulated environment.
- BioWork training or equivalent industrial, military, or vocational training combined with experience.
- Experience with systematic, data-based problem solving, investigations, event response, and preventing recurrence.
- Basic biology, chemistry, and mechanical knowledge, including troubleshooting mechanical components and systems.
- Experience with work permits, Lockout/Tagout systems, and motorized vehicle operation.
Culture & Benefits
- Paid time off, including 14 paid holidays.
- Health, dental, and vision insurance effective from the first day.
- Guaranteed 8% 401(k) contribution with an individual company match option.
- Paid parental and family medical leave, life and disability insurance, and tuition assistance.
- Annual performance bonus and access to Novo Nordisk-marketed pharmaceutical products.
- Career development resources, mentorship, and an inclusive recruitment process.
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