Project Engineer

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

Location: Hybrid, 3 days a week on-site – Franklin, TN

Position Overview

Our client, a leader in manufacturing, is seeking a Project Engineer to support the transfer of a manufacturing process from one contract manufacturer to another. This engineer will serve as the primary technical liaison between the external Contract Manufacturing Organization (CMO) and the client's internal cross-functional teams throughout the technology transfer, supporting sterile injectable biologic drug products across process development, transfer, qualification, validation, regulatory support, and commercial manufacturing readiness.

Key Responsibilities

• Lead and support end-to-end bioprocess technology transfer activities, including process adaptation, scale-up, equipment qualification, validation, and commercial readiness
• Coordinate manufacturing setup and execution with the CMO
• Serve as the primary engineering liaison between the CMO and internal Operations, Manufacturing, Quality, Regulatory Affairs, Product Management, and Project Management teams
• Partner closely with the assigned Project Manager throughout the duration of the project
• Lead technical discussions, resolve issues, and communicate project status, risks, and recommendations to leadership
• Conduct engineering gap assessments and technical risk evaluations using structured methodologies such as FMEA
• Support regulatory submissions, Biologics License Application (BLA) supplements, inspection readiness, and technical justifications related to manufacturing transfers
• Support analytical test method transfer activities, IQ, OQ, PQ, GMP, non-GMP, engineering, and PPQ campaign execution — including review of protocols, reports, batch records, and technical documentation to ensure compliance with regulatory expectations, quality standards, and project timelines
• Manage engineering change strategies, ECOs, and documentation release activities through change control systems
• Perform other duties as assigned to support Product Transfer and Technical Operations

Required Qualifications

• Master's or Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or Engineering preferred, with ~4+ years of relevant experience; Bachelor's degree candidates considered with additional relevant industry experience beyond 4 years
• Minimum 4 years of engineering experience in biotechnology, biologics, pharmaceutical, or medical device industries
• Minimum 4 years supporting technology transfer, manufacturing engineering, process engineering, validation, or scale-up in FDA-regulated cGMP environments
• Strong bioprocessing/manufacturing expertise is the highest priority — more critical than prior technology transfer experience, though transfer experience is preferred
• Experience working with CMOs and in regulated biologics environments strongly preferred