Bioprocess Tech Transfer Engineer (Biologics)

IntePros; Franklin (TN); Hybrid; USD 95,000 - 125,000; Full time

Job summary

IntePros is seeking a Project Engineer to support the transfer of a manufacturing process for sterile biologics at Franklin, TN in a hybrid on-site setting. You will act as the primary technical liaison between the external CMO and internal Operations, QA, Regulatory, Product Management, and Project Management teams.

The role requires strong bioprocessing expertise, 4+ years in biotech/pharma, and experience coordinating CMOs in cGMP environments, with hands-on process optimization and

Qualifications

• 4+ years engineering experience in biotech/pharma/medical devices.
• Experience with technology transfer, manufacturing engineering, validation in cGMP environments.
• Strong bioprocessing/manufacturing expertise prioritized over transfer experience.
• Experience working with CMOs in regulated biologics environments.

Responsibilities

• Lead end-to-end bioprocess technology transfer activities including scale-up and validation.
• Coordinate manufacturing setup and execution with the CMO.
• Serve as engineering liaison between the CMO and internal cross-functional teams.
• Partner with the Project Manager and lead technical discussions and risk assessments.
• Support regulatory submissions, inspections readiness, and technical justifications.
• Review protocols, reports, and documentation to ensure regulatory compliance.
• Manage change control activities and ECO/document release.

Skills

Bioprocessing

Technology transfer

FMEA

GMP knowledge

Regulatory liaison

Education

Master's or Ph.D. in Chemistry/Biochemistry/Engineering

Bachelor's with 4+ years experience

Job description

IntePros is seeking a Project Engineer to support the transfer of a manufacturing process for sterile biologics at Franklin, TN in a hybrid on-site setting. You will act as the primary technical liaison between the external CMO and internal Operations, QA, Regulatory, Product Management, and Project Management teams.

The role requires strong bioprocessing expertise, 4+ years in biotech/pharma, and experience coordinating CMOs in cGMP environments, with hands-on process optimization and