Sr. Manufacturing process Engineer - Pharma-biotech only

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.