Senior Clinical Process Engineer: Lead Global Process Excellence

AbbVie Inc.; Lake Forest (CA); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie seeks a Senior Manager, Clinical Process Engineer to lead design, optimization, and sustainment of clinical business processes across multiple domains. The role involves driving cross-functional alignment, translating complex challenges into fit-for-purpose solutions, and ensuring inspection readiness and quality by design.

The position requires strong project leadership, executive communication skills, and experience in a regulated clinical development environment.

Qualifications

• Bachelor's degree in engineering, life sciences, business or related field required.
• Lean Six Sigma certification required; Green Belt or Black Belt preferred.
• Minimum 7 years of demonstrated experience in process design, process engineering, and/or process improvement within a regulated environment (GxP, clinical development, quality systems, or similar).

Responsibilities

• Lead end-to-end process design and optimization across clinical domains or workstreams.
• Advise on process strategy, design decisions, and tradeoffs for BPOs and functional leaders.
• Develop and govern process maps, SOP-aligned content, and documentation standards.
• Perform current-state assessments and multi-variable analyses to surface issues and opportunities.
• Design and lead complex process design workshops with multi-stakeholder environments.
• Ensure designs are inspection-ready, quality by design, and sustainable.
• Lead process-to-system translation with technology teams and program leadership.
• Define and implement process performance frameworks and KPIs.

Skills

Process design

Stakeholder management

Regulatory compliance

Analytical skills

Education

Bachelor's degree in engineering or life sciences

Lean Six Sigma Green Belt/Black Belt

Job description

AbbVie seeks a Senior Manager, Clinical Process Engineer to lead design, optimization, and sustainment of clinical business processes across multiple domains. The role involves driving cross-functional alignment, translating complex challenges into fit-for-purpose solutions, and ensuring inspection readiness and quality by design.

The position requires strong project leadership, executive communication skills, and experience in a regulated clinical development environment.