Principal Process Engineer – API + OSD

BW Design Group; Philadelphia (Philadelphia County); On-site; USD 250,000 - 275,000; Full time

Job summary

A leading design firm in Philadelphia is seeking a Principal Process Engineer to lead the Life Science Commercial Team. The role involves the design and development of cutting-edge API and OSD processes. Qualified candidates will have a minimum of 20 years of experience in pharmaceutical engineering and a strong understanding of regulatory standards. Compensation ranges from $250,000 to $275,000, and the position is full-time with responsibilities across multiple teams in management and manufacturing.

Qualifications

• Minimum 20 years of experience in pharmaceutical and biologics process system engineering/design.
• Deep knowledge of FDA and EMA regulatory standards, cGMP compliance.
• Proven ability to generate and support business development proposals.

Responsibilities

• Lead front-end design programming for API and OSD processes.
• Drive technical business development activities.
• Collaborate with Manufacturing, Facilities, Quality and Validation teams.

Skills

Pharmaceutical and biologics process system engineering

API synthesis routes

Business development proposals

Communication skills

Regulatory standards knowledge

Education

BS in Chemical, Mechanical or Bio Engineering

Job description

Principal Process Engineer – API + OSD

Join BW Design Group to lead the Life Science Commercial Team as a Principal Process Engineer. You will partner with industry leaders and clients to design and develop cutting‑edge API and OSD processes.

What You’ll Do

• Lead front‑end design programming for API and OSD processes, including site survey, space programming, equipment evaluation, economic analysis, risk assessment and regulatory impact reviews.
• Drive technical business development activities: participate in client presentations, contribute to proposals, author publications, and present at industry conferences.
• Serve as the subject‑matter expert on API/OSD processing operations, regulatory guidance, emerging technologies and OEM supplier community.
• Collaborate closely with Manufacturing, Facilities, Quality and Validation teams to ensure compliance with Good Manufacturing Practices.
• Develop process system engineering from concept to detail design, optimize unit operations, create master batch records, SOPs and conduct technology transfer.

What You’ll Bring

• Minimum 20 years of pharmaceutical and biologics process system engineering/design experience.
• Extensive experience in API synthesis routes, unit operation sequencing from laboratory to commercial scale and technology evaluation.
• Proven ability to generate and support business development proposals and lead front‑end feasibility studies.
• Deep knowledge of FDA and EMA regulatory standards, cGMP compliance and inspection experience.
• Strong communication skills and the ability to travel as required for project activities.
• BS degree in Chemical, Mechanical or Bio Engineering (preferred). Other engineering degrees considered based on experience.

Compensation

Approximate pay range $250 000 – $275 000. Final compensation may vary based on experience and location.

Seniority level

Associate

Employment type

Full‑time

Job function

Management and Manufacturing