Director, Aseptic Process Engineering

Blackfield Associates; North Carolina; On-site; USD 180,000 - 240,000; Full time

Job summary

Blackfield Associates is collaborating with a global pharmaceutical client to recruit a Process Engineering Director for a North Carolina location on a full-time permanent basis.

You will provide strategic leadership for process engineering across aseptic manufacturing, including design, commissioning, qualification, and start-up activities. Build high-performing teams, manage vendor relations, and ensure cGMP compliance and regulatory alignment.

Qualifications

• Bachelor’s degree in Mechanical or Chemical engineering or related field.
• 5+ years leading engineering teams on large capital projects.
• Experience with cGMP biopharmaceutical or aseptic manufacturing.
• Strong regulatory knowledge (FDA/EU) and project controls.

Responsibilities

• Provide leadership for process engineering across design, qualification and start-up of aseptic facilities.
• Oversee facility design, vendor selection, and commissioning activities.
• Ensure compliance with cGMP, regulatory expectations, and project objectives.
• Mentor and develop high‑performing engineering teams.
• Collaborate with Manufacturing, Quality, MSAT, Facilities, Procurement, and EHS.

Skills

Leadership

Cross-functional

Stakeholder management

Technical leadership

Strategic thinking

Education

Bachelor degree (Mechanical/Chemical)

Advanced degree preferred

Job description

Blackfield Associates is collaborating with a global pharmaceutical client to recruit a Process Engineering Director for a North Carolina location on a full-time permanent basis.

You will provide strategic leadership for process engineering across aseptic manufacturing, including design, commissioning, qualification, and start-up activities. Build high-performing teams, manage vendor relations, and ensure cGMP compliance and regulatory alignment.