Process Development Engineer: GMP Validation & Tech Transfer

Barry-Wehmiller Companies Inc.; Raleigh (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

Barry-Wehmiller Companies Inc. is seeking a Process Development Engineer to advance validation, technology transfer, and manufacturing optimization for biotech/pharma clients in the Raleigh area.

You will lead cross-functional teams, develop validation master plans, and ensure compliance with FDA/ICH guidelines, leveraging 5–10 years of GMP experience and strong DOE skills. This role offers growth within a world-class engineering group.

Qualifications

• B.S. or higher in a technical discipline related to pharmaceutical manufacturing (chemical/biomedical/pharma engineering).
• 5–10 years of experience in pharmaceutical or biotechnology GMP environments.
• Proven expertise in process, cleaning, and equipment validation.
• Knowledge of FDA requirements and ICH Q8/Q9/Q10 principles.
• Strong problem-solving and cross-functional leadership in GMP settings.

Responsibilities

• Prepare validation/qualification protocols and documentation for new or modified manufacturing processes.
• Conduct validation tests of processes, equipment, or software per internal/external standards.
• Develop validation master plans, process flow diagrams, test cases, or SOPs.
• Develop and document process understanding strategies aligned with ICH Q8 with design space and control strategy justification.
• Execute quality risk management activities per ICH Q9, including FMEA, risk assessment, and risk control.
• Establish and implement integrated control strategies per ICH Q10.
• Lead investigations and troubleshooting of deviations; support technology transfer.
• Assist with continuous improvements to safety, robustness, efficiency, and cost performance.

Skills

Process validation

GMP experience

Process development

ICH Q8/Q9/Q10 knowledge

DOE and statistics

Regulatory liaison

Troubleshooting

Scale-up/tech transfer

Upstream/downstream processing

Documentation discipline

Education

B.S. or higher in a technical discipline related to pharmaceutical manufacturing

Job description

Barry-Wehmiller Companies Inc. is seeking a Process Development Engineer to advance validation, technology transfer, and manufacturing optimization for biotech/pharma clients in the Raleigh area.

You will lead cross-functional teams, develop validation master plans, and ensure compliance with FDA/ICH guidelines, leveraging 5–10 years of GMP experience and strong DOE skills. This role offers growth within a world-class engineering group.