Site Process SME & Improvement Lead

Biopharma Careers; Petersburg (VA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

8% 401K with company match

Paid parental leave

Paid family medical leave

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Paid holidays

Job summary

Novo Nordisk is expanding its Petersburg, VA site to strengthen Emerging Technologies in Chemical API development and production. The Site SME will lead strategic projects, mentor Process Professionals, and coordinate with vendors and engineers to meet cost, quality, and schedule targets.

The role requires strong Lean/Six Sigma experience, extensive validation knowledge, and a background with GMP regulations.

Qualifications

• Bachelor’s degree (engineering, technology or related field) from an accredited university required and minimum of eight (8) years of manufacturing experience
• LEAN manufacturing experience and training required
• Thorough validation knowledge and experience required (product/tech transfer preferred)
• General experience with regulatory audits/inspections required
• Thorough knowledge of relevant electronic manufacturing systems and master data (e.g., SAP, PAS-X)
• Demonstrated knowledge of adult learning methodologies and ability to train and coach others

Responsibilities

• Support senior leadership as part of the department management group through participating in strategic discussions and decision making
• Responsible for area content and process knowledge, periodic reviews, validation processes, and reporting
• Demonstrate technical knowledge to promote continuous improvement, increased productivity, and cost reduction
• Facilitate and provide technical oversight for assigned processes, including assessment of deviations, root cause analysis, validation and process changes/improvements
• Present as the technical expert for assigned processes to auditors/inspectors
• Collaborates and shares best practices with other departments and other sites
• Provide support to other areas in matters related to knowledge of assigned production/process area
• Lead and provide guidance related to complex maintenance matters
• Communicate production and industry trends to team and shop floor to drive cGMP
• Implement new technologies for the process/maintenance, planning and coordinating of changes according to regulatory procedures
• Follow all safety & environmental requirements in the performance of duties

Skills

Lean manufacturing

Six Sigma

Root cause analysis

Change control

Audits/inspections

Technical leadership

Communication

Process optimization

Education

Bachelor’s degree in engineering/technology or related field

Associate’s degree in engineering/technology (alternative)

High School Diploma with 12 years manufacturing experience (alternative)

Tools

SAP

PAS-X

Job description

Novo Nordisk is expanding its Petersburg, VA site to strengthen Emerging Technologies in Chemical API development and production. The Site SME will lead strategic projects, mentor Process Professionals, and coordinate with vendors and engineers to meet cost, quality, and schedule targets.

The role requires strong Lean/Six Sigma experience, extensive validation knowledge, and a background with GMP regulations.