Pharma Process Improvement Associate (Lean & GMP)

Novo Nordisk; Clayton (NC); Presencial; USD 85.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Performance bonus

Paid holidays

Health insurance

Dental insurance

Vision insurance

401K match

Parental leave

Tuition assistance

Life & disability insurance

Referral program

Descripción de la vacante

Novo Nordisk is seeking a process-focused professional to support operations in Fill & Finish Expansions (FFEx). You will work with production and QA to investigate deviations, perform root-cause analysis, and implement Lean-based improvements across aseptic and solid dosage processes.

Training junior staff and ensuring regulatory compliance are key parts of the role. This role requires a bachelor’s (or equivalent) in engineering/tech, GMP knowledge, and a proactive approach to problem solving.

Formación

• Bachelor’s degree required in engineering, technology or related field
• Associate’s degree with 2+ years manufacturing experience considered
• High School Diploma with 4+ years manufacturing experience considered
• Minimum 1 year of manufacturing experience preferred (pharmaceutical)
• Excellent written communication skills required
• GMP knowledge required
• Basic investigation and systematic problem-solving experience required
• Manufacturing experience preferred
• Knowledge of change control and QMS systems preferred
• Exposure to regulatory audits/inspections a plus
• Experience with electronic manufacturing systems (SAP, PAS-X) preferred

Responsabilidades

• Assist with deviation investigations and root cause analysis with production and QA
• Drive continuous improvements using Lean tools
• Provide training on process and procedure changes to staff
• Identify and implement process improvements for routine to moderate complexity issues
• Collect data for periodic reviews and reporting
• Adhere to safety and environmental requirements in duties
• Other accountabilities as assigned

Conocimientos

Excellent written communication

GMP knowledge

Adult learning methodologies

Problem solving

Educación

Bachelor’s degree in engineering/technology or related field

Associate’s degree with 2 years manufacturing experience

High School Diploma with 4 years manufacturing experience

Herramientas

SAP

PAS-X

Descripción del empleo

Novo Nordisk is seeking a process-focused professional to support operations in Fill & Finish Expansions (FFEx). You will work with production and QA to investigate deviations, perform root-cause analysis, and implement Lean-based improvements across aseptic and solid dosage processes.

Training junior staff and ensuring regulatory compliance are key parts of the role. This role requires a bachelor’s (or equivalent) in engineering/tech, GMP knowledge, and a proactive approach to problem solving.