Pharma Process Development Engineer: Validation & Transfer

BW Design Group; Raleigh (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

BW Design Group is seeking a Process Development Engineer to support biotechnology and pharmaceutical clients with robust validation, technology transfer, troubleshooting, and manufacturing optimization.

The ideal candidate has 5–10 years in GMP environments, expertise in process/cleaning/equipment validation, and a strong knowledge of ICH Q8/Q9/Q10. You will work with cross-functional teams to ensure high-quality, compliant processes across diverse modalities.

Qualifications

• BS in a technical discipline related to pharmaceutical manufacturing.
• 5–10 years of experience in pharma/biotech GMP environments.
• Expertise in process, cleaning, and equipment validation.
• Knowledge of FDA/ICH Q8/Q9/Q10 guidelines and lifecycle approach.
• Experience with design spaces, control strategies, and DOE.

Responsibilities

• Prepare validation/qualification protocols and documents for new or modified processes, systems, or equipment.
• Conduct validation tests per internal/external standards.
• Develop validation master plans, process flow diagrams, and SOPs.
• Lead investigations and troubleshoot deviations; support technology transfer.
• Partner with regulatory affairs to align validation strategies with FDA expectations.
• Collaborate with manufacturing, quality, process development, and regulatory teams.

Skills

GMP experience

Process validation

DOE

Regulatory liaison

Cross-functional teams

Root cause analysis

Technology transfer

Documentation discipline

Education

B.S. in chemical/biomedical/pharma engineering

Job description

BW Design Group is seeking a Process Development Engineer to support biotechnology and pharmaceutical clients with robust validation, technology transfer, troubleshooting, and manufacturing optimization.

The ideal candidate has 5–10 years in GMP environments, expertise in process/cleaning/equipment validation, and a strong knowledge of ICH Q8/Q9/Q10. You will work with cross-functional teams to ensure high-quality, compliant processes across diverse modalities.