Aseptic Process Improvement Specialist

Novo Nordisk

Clayton (NC)

On-site

USD 90,000 - 130,000

Full time

14 days+

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Benefits offered by this job

Leading pay and annual performance/bon

14 paid holidays

Health Insurance

Dental Insurance

Vision Insurance

401K with company match

Parental leave

Life & Disability Insurance

Tuition Assistance

Employee Referral Awards

Job summary

Novo Nordisk in Clayton, NC, invites a Sr Process Professional to support our FFEx operations, people, equipment, and processes. You will train peers, provide SME guidance, and deliver solutions for moderate to high complexity issues while mentoring junior team members.

Key responsibilities include leading deviation investigations, driving Lean/Six Sigma improvements, and maintaining process knowledge. This role involves cross-site collaboration and adherence to safety and regulatory

Qualifications

Bachelor’s degree in engineering, technology or related field from an accredited university.
Associate’s degree with 4+ years manufacturing experience in tech/manufacturing.
High School Diploma with 6+ years manufacturing experience.
Minimum 2+ years manufacturing experience, preferably pharma manufacturing.
Excellent written communication skills.
Investigation and systematic problem-solving experience.
LEAN manufacturing experience and training.
Knowledge of Change Control systems and QMS.
Experience with SAP, PAS-X or similar electronic manufacturing systems.
Adult learning methodologies and training/coaching ability preferred.
Regulatory audits/inspections experience.
Knowledge of master data (preferred).
Validation experience (preferred).
Product transfer/tech transfer experience a plus.

Responsibilities

Support people, equipment and processes in operations to meet business and regulatory requirements.
Support training for lower-level peers and demonstrate SME in assigned area.
Provide solutions for moderate to high complexity process issues.
Back-up for Sr Process Professional and mentor juniors.
Lead in depth deviation investigations and root cause analysis.
Drive continuous improvements via Lean and Six Sigma methodologies.
Maintain area content and process knowledge.
Identify and implement process improvements for moderate to high complexity issues.
Periodic reviews and cross-site collaboration.
Update area master data and recipes.
Support defined issues with expertise and knowledge.
Follow safety and environmental requirements.
Other duties as assigned.