Sr. Manufacturing process Engineer - Pharma-biotech

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Job Title:
Manufacturing Process Engineer – Cell Therapy MS&T

Location:
Durham, NC (Fully Onsite, 5 Days/Week)

Hours/Week: 40

Position Summary:

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.

Key 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 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 & Leachables (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.

Qualifications:

• Bachelor’s or advanced degree in Biology, Biochemistry, Chemical Engineering, or a related field.
• 7–10 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.

• Mid-Senior level

• Contract

• Engineering and Health Care Provider
• Industries:
  Pharmaceutical Manufacturing and Biotechnology Research

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