Manufacturing Process Engineer

Katalyst CRO; Durham (NC); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading company in cell therapy is seeking a Manufacturing Process Engineer to join their Manufacturing Science and Technology team. This role involves implementing process control strategies, analyzing performance data, and ensuring compliance with regulatory standards in a collaborative environment.

Qualifications

• 8-10 years of hands-on MS&T or manufacturing engineering experience in GMP cell/gene therapy environment.
• Strong knowledge of cGMP, ICH, and FDA guidelines.
• Experience with single-use systems and sterile manufacturing is highly preferred.

Responsibilities

• Implement and support late-stage manufacturing process control strategies for cell therapy drug product.
• Analyze and monitor process performance data to ensure process consistency.
• Support tech transfer activities and execution of late-stage PD deliverables.

Skills

Process control strategy implementation

Risk assessment

GMP operations

Manufacturing support

Technical excellence

Collaboration skills

Education

Bachelor's or advanced degree in Biology, Biochemistry, Chemical Engineering, or related field.

Job description

Job Description

We are seeking a Manufacturing Process Engineer to join the Manufacturing Science and Technology (MS&T) team, supporting late-stage manufacturing and PPQ readiness for an autologous cell therapy product. This role requires a strong background in GMP operations, process control strategy implementation, risk assessment, and manufacturing support. The engineer will serve as a subject matter expert (SME) driving technical excellence, ensuring process robustness, and supporting regulatory compliance in a cross-functional environment.

Responsibilities

• Implement and support late-stage manufacturing process control strategies for cell therapy drug product.
• Analyse and monitor process performance data to ensure process consistency and readiness for PPQ.
• Collaborate with process development and manufacturing teams to support tech transfer activities and execution of late-stage PD deliverables.
• Participate in the preparation and execution of ancillary PPQ protocols (e.g., buffer stability, intermediate hold times) and summary reports.
• Contribute to risk assessments, including Extractables & Leachable (E&L), and consumables qualification.
• Support the selection and justification of single-use systems and sterile processing equipment.
• Review and interpret SOPs and execute work instructions related to manufacturing readiness and qualification efforts.
• Act as an MS&T representative in cross-functional investigations, leading or supporting root cause analysis and proposing data-driven corrective actions.
• Ensure alignment with cGMP, FDA, ICH, and internal quality standards throughout all activities.
• Engage proactively with cross-functional stakeholders to ensure manufacturing processes meet regulatory and operational expectations.
  
  

Requirements:

• Bachelor's or advanced degree in Biology, Biochemistry, Chemical Engineering, or a related field.
• 810 years of hands-on MS&T or manufacturing engineering experience in a GMP cell/gene therapy environment.
• Strong knowledge of PPQ, PV lifecycle, cGMP, ICH, and FDA guidelines.
• Proven experience supporting late-stage tech transfer and manufacturing process implementation.
• Familiarity with risk management tools and E&L assessments.
• Experience with single-use systems, sterile manufacturing, and consumables qualification is highly preferred.
• Excellent skills in interpreting and executing SOPs and contributing to protocols and technical reports.
• Effective communicator with strong collaboration skills and the ability to work independently with minimal supervision.