Aseptic Process Improvement Engineer I

BioSpace; Clayton (NC); Sur place; USD 70 000 - 100 000; Plein temps

Avantages offerts par ce poste

Leading pay bonus

14 holidays per year

Health, dental, vision insurance

401K with company match

Parental leave and family medicalLeave

Education reimbursement

Life & disability insurance

Employee referral programs

Résumé du poste

Novo Nordisk is seeking a Manufacturing Process Support role in Clayton, NC, to assist with operations in FFEx, covering aseptic production, quality systems, and continuous improvement initiatives. The position emphasizes deviation investigations, data collection, and training to support junior team members.

You will collaborate with production, QA, and IT in a global manufacturing environment, ensuring regulatory compliance and safe, efficient processes.

Qualifications

• Bachelor’s degree (engineering, technology or related field of study preferred) from an accredited university required
• May consider an Associate’s degree from an accredited university with a minimum of two (2) years of manufacturing experience required
• May consider a High School Diploma (GED) with a minimum four (4) years of manufacturing experience required
• Minimum of one (1) year of manufacturing experience preferred, preferably in a pharmaceutical manufacturing environment
• Excellent Written Communication Skills Required
• GMP knowledge required
• Manufacturing Experience Preferred
• Basic investigation and systematic problem-solving experience required
• General knowledge of change control and Quality Management System (QMS) systems preferred
• Relevant electronic manufacturing system experience preferred (ex: SAP, PAS-X, etc)
• Demonstrated knowledge of adult learning methodologies and ability to use multiple methods to train others preferred
• Exposure to regulatory audits/inspections a plus

Responsabilités

• Work with production and QA to provide in depth deviation investigations and root cause analysis
• Drive continuous improvements via Lean tools
• Provide training on process and procedure changes
• Identify and implement process needs and improvement opportunities for routine to moderate complexity issues
• Responsible for collection of data for periodic reviews and reporting
• Follow all safety & environmental requirements in the performance of duties

Description du poste

Novo Nordisk is seeking a Manufacturing Process Support role in Clayton, NC, to assist with operations in FFEx, covering aseptic production, quality systems, and continuous improvement initiatives. The position emphasizes deviation investigations, data collection, and training to support junior team members.

You will collaborate with production, QA, and IT in a global manufacturing environment, ensuring regulatory compliance and safe, efficient processes.