Pharmaceutical Operator - FFEx (AP-Filling)

Initial Therapeutics, Inc.; Clayton (NC); On-site; USD 40,000 - 80,000; Full time

Job summary

Ein innovatives Unternehmen sucht nach einem engagierten Mitarbeiter für die aseptische Produktion. In dieser Rolle unterstützen Sie den Aufbau und die Validierung neuer Produktionsanlagen, um höchste Standards in der aseptischen Verarbeitung zu gewährleisten. Sie werden Teil eines dynamischen Teams, das sich der Verbesserung der Produktionskapazitäten widmet, um Millionen von Patienten weltweit zu bedienen. Mit einem starken Fokus auf moderne Technologien und einem unterstützenden Umfeld bietet dieses Unternehmen zahlreiche Möglichkeiten zur beruflichen Weiterentwicklung und ein umfassendes Leistungspaket, das Ihre Karriere voranbringen wird.

Benefits

Leistungsorientierte Vergütung und jährlicher Bonus

Großzügige bezahlte Freizeit, einschließlich 14 bezahlter Feiertage

Gesundheits-, Zahn- und Augenversicherung – ab dem ersten Tag

Garantierte 8% 401K-Beiträge plus Unternehmensbeitrag

Familienfreundliche Leistungen: 14 Wochen bezahlter Elternurlaub

Kostenlose Produkte von Novo Nordisk

Studienhilfe

Lebens- und Invaliditätsversicherung

Mitarbeiterempfehlungsprämien

Qualifications

• Mindestens zwei Jahre Erfahrung in einem FDA-regulierten Umfeld.
• Erfahrung in der aseptischen Verarbeitung erforderlich.

Responsibilities

• Überprüfen und Verfassen von Arbeitsanweisungen und SOPs.
• Unterstützen beim Start-up und der Validierung neuer Geräte.

Skills

Aseptische Verarbeitung

Dokumentation interpretieren

Planungs- und Organisationsfähigkeiten

Computerkenntnisse

Education

High School Diplom oder gleichwertig

Job description

About the Department

You will be joining Fill & Finish Expansions (FFEx), responsible for major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, employing approximately 20,000 of Novo Nordisk’s 50,000 employees globally.

FFEx is a newly established and growing area tasked with designing, planning, and building new aseptic filling capacity across Novo Nordisk to serve millions of patients. We aim to innovate our production facilities with modern technology, setting standards for the future of aseptic production. Facilities designed today will still be relevant in 20 years. FF Expansions collaborates globally, working across multiple sites and cultures.

What we offer you:

• Leading pay and annual performance bonus
• Generous paid time off, including 14 paid holidays
• Health, Dental, and Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus company match
• Family-focused benefits: 14 weeks paid parental leave & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

At Novo Nordisk, we provide opportunities, resources, and mentorship to grow your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

The Position

Assist in developing the structure to operate aseptically in Formulation, Wash/Sterilization, Filling, & media preparations through documentation, start-up, and validation activities for a new production facility.

Relationships

Reports to Manager.

Essential Functions

• Review & author Job Instructions, SOPs & other documents
• Assist in the start-up and validation of new equipment
• Review standards to maintain aseptic areas & perform sanitizations & environmental monitoring
• Support event response planning
• Assist maintenance team in developing protocols for restoration of lost functions, predictive & preventative maintenance
• Support SMEs in training employees, including learning systems & equipment outside of their expertise
• Follow all safety & environmental requirements
• Other duties as assigned

Physical Requirements

Moves equipment &/or supplies weighing up to 33 pounds, operates & inspects manufacturing equipment, and may work in cold, loud, or hazardous environments, including confined spaces, elevated heights, or around odorous materials. May require vision correction, color vision, motor vehicle operation, and wearing protective gear.

Qualifications

• High school diploma or equivalent
• Minimum two (2) years of experience in an FDA regulated environment
• Aseptic processing experience required
• Isolator experience preferred
• Ability to interpret complex documentation and SOPs
• Computer literacy
• Planning, organizing, and managing work skills preferred

We are committed to an inclusive recruitment process and equal opportunity employment. We celebrate diversity and are dedicated to creating an inclusive culture for our employees, patients, and communities. Qualified applicants will receive consideration without regard to race, ethnicity, religion, sex, gender identity, sexual orientation, national origin, disability, veteran status, or other protected characteristics.

If you need assistance or accommodations to apply, please call 1-855-411-5290. This contact is for accommodation requests only.