Senior API/OSD Process Engineer – Life Sciences

Barry-Wehmiller Companies Inc.; Raleigh (NC); On-site; USD 170,000 - 240,000; Full time

Job summary

Barry-Wehmiller’s BW Design Group seeks a Principal Process Engineer in the US to join a team of industry experts shaping manufacturing and technology. You will solve complex API/OSD process challenges for top clients, guiding design, transfer, and regulatory readiness end-to-end.

You will work on front-end design, feasibility, risk assessments, and industry leadership activities. A BS in engineering and 20+ years in pharma/biologics are preferred; travel may be required.

Qualifications

• 20+ years of pharma/biologics process engineering/design experience.
• Experience with proposal generation and business development.
• Front-end/feasibility study experience.
• Expertise in sterilization, aseptic filling, sealing, and sterile drug products.
• Knowledge of process definition means and methods.
• Experience with FDA/EMA regulatory standards.
• Excellent communication and interpersonal skills.
• Proficiency with AutoCAD, Microsoft Office, and MS Project.
• Willingness to travel for project needs.

Responsibilities

• Lead front-end design, programming for API/OSD processes with site surveys and equipment evaluation.
• Perform economic analysis, risk assessments, regulatory impact reviews.
• Develop tech transfer plans, Master Batch Records, and SOPs.
• Support client engagement, proposals, and thought leadership.
• Ensure compliance with cGMP and regulatory expectations.
• Collaborate with manufacturing, quality, validation and facilities teams.

Skills

Pharma process engineering

Biologics process engineering

Proposal development

Front-end feasibility

Regulatory knowledge

Strong communication

Travel willingness

3D modeling

P&ID knowledge

Education

BS in Chemical/Mechanical/Bio Engineering

Tools

AutoCAD (basic)

Microsoft Project (basic)

Microsoft Office

Job description

Barry-Wehmiller’s BW Design Group seeks a Principal Process Engineer in the US to join a team of industry experts shaping manufacturing and technology. You will solve complex API/OSD process challenges for top clients, guiding design, transfer, and regulatory readiness end-to-end.

You will work on front-end design, feasibility, risk assessments, and industry leadership activities. A BS in engineering and 20+ years in pharma/biologics are preferred; travel may be required.