Lead Process Engineer – Life Sciences & cGMP

BW Design Group; Raleigh (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

BW Design Group seeks a Department Manager, Process to lead a team of process engineers and designers in delivering high-quality, compliant process designs for life sciences manufacturing. You will work with clients to develop solutions that meet regulatory standards and project goals.

The role requires deep expertise in cGMP and FDA requirements, strong leadership, and the ability to communicate complex technical concepts clearly.

Qualifications

• 10+ years of process engineering design experience in cGMP, FDA, or regulated manufacturing environments.
• 2+ years as a process engineering design manager preferred.
• Experience developing process engineering designs for the life sciences industry.
• Demonstrated ability to present process designs to existing and new clients.
• Demonstrated ability to lead a process engineering design team.
• Subject Matter Expert knowledge of cGMP regulations and standards preferred.
• Proficient with Microsoft Office software: Outlook, Word, Excel, PowerPoint.
• Proficient with written and verbal technical communication including generating reports and conducting group presentations.
• Travel as needed to complete projects.

Responsibilities

• Direct process design activities (including process descriptions, process flow diagrams, and P&IDs).
• Lead a team of process engineers and designers to successfully execute projects meeting cGMP, FDA and other regulatory standards.
• Ensure quality through rigorous project quality reviews.
• Review and approve drawings for client and project needs.
• Review submittals, answer RFIs, and direct field visits to verify onsite work.
• Client development activities include presenting our firm’s process capabilities and proposing technical solutions.
• Build relationships with practice and market sector professionals to deliver cohesive, technically correct operational solutions across firm-wide groups.
• Build and develop the team of process design engineers under your guidance and supervision.

Skills

Process engineering

Team leadership

Client presentations

Regulatory standards

cGMP

Education

ABET accredited degree in mechanical or chemical engineering

Master's degree in engineering a plus

Professional Engineering license preferred

Tools

MS Office

Job description

BW Design Group seeks a Department Manager, Process to lead a team of process engineers and designers in delivering high-quality, compliant process designs for life sciences manufacturing. You will work with clients to develop solutions that meet regulatory standards and project goals.

The role requires deep expertise in cGMP and FDA requirements, strong leadership, and the ability to communicate complex technical concepts clearly.