Staff Product Transfer Project Engineer – Bioprocessing

Comrise; Franklin (TN); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid onsite work 3 days/ week

Remote interviews available

International travel to Austria

Job summary

Comrise is seeking a Staff Product Transfer Project Engineer – Bioprocessing in Franklin, TN. Hybrid-3 onsite days, 18-month contract with possible extension.

Lead technology transfer for biologics with CMOs and internal sites, ensuring process transfer, validation, and manufacturing readiness. The role requires strong biologics manufacturing and bioprocessing experience in FDA-regulated environments, plus cross-functional collaboration with Quality, Regulatory, Validation, and Supply Chain

Qualifications

• Bachelor's degree in engineering or related science required.
• Master's or Ph.D. preferred with 4+ years in biologics/pharma manufacturing.
• Experience in FDA-regulated cGMP environments.

Responsibilities

• Lead end-to-end product and technology transfer for biologics manufacturing.
• Serve as engineering liaison between CMOs and internal teams.
• Support process transfer, scale-up, qualification, validation, and readiness.
• Conduct risk assessments (FMEA) and gap analyses.
• Collaborate with Regulatory Affairs for submissions and inspections.
• Support analytical method transfers and validation protocols.
• Drive ECOs and document management in change control.
• Communicate status and risks to stakeholders.

Skills

Biologics manufacturing

Bioprocess engineering

Technology transfer

FDA-regulated cGMP

Project management

Education

Bachelor's degree in Engineering/related science

Master's or Ph.D. preferred

Tools

FMEA

Job description

Location: Franklin, TN (Hybrid - 3 days onsite)

Duration: 18-Month Contract (Potential Extension)

Travel: Up to 25% (Includes 2-3 international trips to Austria during the project)

Position Overview

We are seeking a Staff Product Transfer Project Engineer – Bioprocessing to lead technology transfer activities for biologic drug products between external manufacturing partners and internal manufacturing sites. This individual will serve as the primary engineering liaison across cross-functional teams, ensuring successful product transfer, process validation, regulatory compliance, and commercial manufacturing readiness.

The ideal candidate has strong experience in biologics manufacturing, bioprocess engineering, and technology transfer within an FDA-regulated cGMP environment. This is a highly collaborative role requiring close interaction with Technical Operations, Quality, Manufacturing, Regulatory Affairs, Validation, Supply Chain, and external Contract Manufacturing Organizations (CMOs).

Key Responsibilities

• Lead end-to-end product and technology transfer activities for biologics manufacturing.
• Serve as the primary engineering liaison between external manufacturing partners (CMOs) and internal cross-functional teams.
• Support process transfer, scale-up, equipment qualification, process validation, and commercial manufacturing readiness.
• Conduct engineering risk assessments and technical gap analyses using tools such as FMEA.
• Collaborate with Regulatory Affairs to support submissions, inspection readiness, and manufacturing change documentation.
• Support analytical method transfers, IQ/OQ/PQ activities, PPQ campaigns, and review validation protocols and technical documentation.
• Drive engineering change control activities, including ECOs and document management.
• Communicate project status, technical risks, and recommendations to project stakeholders and leadership.

Required Qualifications

• Bachelor's degree in Engineering, Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry, or a related scientific discipline required.
• Master's or Ph.D. preferred with at least 4 years of relevant industry experience.
• Candidates with a Bachelor's degree should have more than 4 years of relevant experience in biologics or pharmaceutical manufacturing.
• Experience in biologics, biotechnology, pharmaceutical, or medical device manufacturing.
• Hands-on experience supporting technology transfer, manufacturing engineering, process engineering, validation, or process scale-up.
• Experience working in FDA-regulated cGMP manufacturing environments.
• Strong understanding of biologics manufacturing and bioprocessing.

Preferred Qualifications

• Experience working with Contract Manufacturing Organizations (CMOs).
• Knowledge of upstream and downstream bioprocessing.
• Experience with sterile injectable biologics manufacturing.
• Familiarity with FDA, EMA, ICH, cGMP, and process validation requirements.
• Strong project management and cross-functional leadership skills.

Additional Information

• Hybrid work schedule with 3 days onsite in Franklin, TN.
• Remote interviews are available.
• International travel to Austria is expected approximately 2-3 times during the project.
• This is an 18-month contract with the possibility of extension; conversion to a permanent position is not anticipated.