Processing Engineering Director

Blackfield Associates are currently partnered with a global pharmaceutical manufacturer to support their search for a Process Engineering Director to join their project based in North Carolina on full time permanent basis.

• Provide overall leadership for process engineering activities supporting the design, development, commissioning, qualification, and start-up of a new aseptic drug product manufacturing facility.
• Lead process engineering strategy across manufacturing areas including clean utilities, equipment preparation, compounding, aseptic filling, inspection, packaging, laboratories, and warehouse operations.
• Oversee development and approval of process engineering deliverables, including user requirements, technical specifications, datasheets, and engineering documentation.
• Manage technical aspects of facility and equipment design, ensuring compliance with cGMP requirements, regulatory expectations, and operational objectives.
• Lead vendor evaluations, equipment selection activities, and coordination with engineering firms, contractors, and equipment suppliers.
• Drive resolution of complex process, equipment, and commissioning challenges throughout project execution and start-up.
• Partner with Manufacturing, Quality, MSAT, Facilities, Procurement, Engineering, Construction, and EHS teams to ensure successful project delivery and operational readiness.
• Ensure alignment of engineering solutions with business objectives, project schedules, capital investment strategies, and regulatory requirements.
• Establish and maintain engineering standards, best practices, and continuous improvement initiatives across the organization.
• Build, develop, and mentor high-performing engineering teams while fostering a culture of technical excellence, collaboration, and innovation.
• Provide strategic leadership for engineering decision-making, technology implementation, process optimization, and long-term facility performance.
• Stay current with industry trends, regulatory developments, and emerging technologies to support future manufacturing and facility strategies.

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• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, or a related engineering discipline. Advanced degree preferred.
• Sufficient process engineering, manufacturing, or capital project experience within a cGMP biopharmaceutical or aseptic drug product manufacturing environment.
• Minimum 5 years of leadership experience managing engineering teams and large-scale capital projects.
• Proven experience leading facility design, commissioning, qualification, and start-up activities for aseptic pharmaceutical manufacturing facilities.
• Strong knowledge of aseptic manufacturing processes, FDA and EU regulatory requirements, and Annex 1 guidance.
• Extensive experience managing multidisciplinary engineering teams, contractors, equipment vendors, and external engineering partners.
• Deep understanding of facility design, project controls, construction execution, procurement, commissioning, and qualification processes.
• Demonstrated success delivering large-scale pharmaceutical capital projects and driving operational readiness for new manufacturing facilities.
• Strong technical problem-solving, communication, stakeholder management, and decision‑making skills.
• Experience leading greenfield pharmaceutical manufacturing projects is highly desirable.
• Proven ability to build high-performing teams, influence senior stakeholders, and drive engineering excellence across complex organizations.