Executive Director, Aseptic DP Process Engineering

jj; Charlotte (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

Johnson & Johnson in Wilson, North Carolina, seeks a Director of Aseptic DP Process Engineering to lead end-to-end process engineering for a new DP aseptic manufacturing node. You will design facilities, ensure cGMP compliance, and mentor a high-performing team.

The role requires 15+ years in biotherapeutics, 5+ years of leadership, and strong cross-functional collaboration with Manufacturing, Facilities, MSAT, Quality, and Regulatory teams. On-site with travel.

Qualifications

• Bachelor's degree in engineering required (Mechanical or Chemical preferred).
• 15+ years in drug product within a biotherapeutics cGMP environment.
• 5+ years of people leadership experience.
• Strong partnerships across organizational levels; multicultural team leadership.
• Ability to drive design, commissioning, and qualification of aseptic facilities.
• Solid understanding of EU/US regulatory requirements and Annex 1.

Responsibilities

• Develop and deliver process engineering specifications (URDs, data sheets, specs).
• Assess vendor competency, review bid documents, and manage project execution.
• Resolve technical issues during C&Q and readiness for start-up.
• Collaborate across Manufacturing, Facilities, MSAT, Quality, Procurement, E&PS, and EHS.
• Mentor engineering team and apply data-driven insights for decisions.

Skills

Process Engineering

Leadership

Project Management

Stakeholder Engagement

Regulatory Compliance

cGMP Knowledge

Problem Solving

Cross-functional Collaboration

Vendor & Capital Projects

Data-driven Decision Making

Education

Bachelor's Degree in Engineering

MS or MBA preferred

Job description

Johnson & Johnson in Wilson, North Carolina, seeks a Director of Aseptic DP Process Engineering to lead end-to-end process engineering for a new DP aseptic manufacturing node. You will design facilities, ensure cGMP compliance, and mentor a high-performing team.

The role requires 15+ years in biotherapeutics, 5+ years of leadership, and strong cross-functional collaboration with Manufacturing, Facilities, MSAT, Quality, and Regulatory teams. On-site with travel.