Director, Aseptic DP Process Engineering (Biotherapeutics)

Location: Wilson, North Carolina, United States; full-time on-site support required. Frequent travel of more than 75% is required to the engineering firm until the project shifts to the Wilson plant site.

Company

Johnson & Johnson develops healthcare, pharmaceutical, and medical technology solutions, including innovative medicines for complex diseases.

What you will do

• Lead end-to-end process engineering for the equipment and facility design of a new aseptic drug product manufacturing site.
• Develop process engineering specifications, including user requirements, data sheets, and technical specifications.
• Assess vendors, review bid documents, and oversee project development, execution, and process system performance.
• Resolve technical issues during commissioning and qualification testing and prepare systems for start-up.
• Coordinate Manufacturing, Facilities, MSAT, Quality, Procurement, Engineering & Property Services, and EHS stakeholders.
• Build and mentor a high-performing engineering team while promoting technical excellence, collaboration, and innovation.

Requirements

• Bachelor’s degree in engineering required; Mechanical or Chemical Engineering preferred. An MS or MBA is preferred.
• 15+ years of drug product experience in a biotherapeutics cGMP environment, preferably in process engineering or capital project execution.
• 5+ years of people leadership experience with a record of developing high-performing teams.
• Strong knowledge of aseptic manufacturing cGMP requirements, including EU Annex 1, FDA requirements, EHS by design, construction safety, and facility and equipment design.
• Experience with start-up, commissioning and qualification, construction and procurement, project controls, and project scheduling.
• Strong technical, problem-solving, communication, decision-making, stakeholder management, and multicultural team leadership skills.

Nice to have

• Experience leading capital projects valued at $250–500 million.
• Process engineering expertise from conceptual design through commissioning and qualification in a biotherapeutic drug product environment.
• Leadership experience on greenfield projects.

Culture & Benefits

• Inclusive environment focused on respect, diversity, and individual contribution.
• Collaboration with an engineering firm and multiple global business functions.
• Opportunity to contribute to engineering innovation, technical knowledge sharing, and talent development.
• Work supporting the design and start-up of a new manufacturing node.