Date Posted: 07/29/2026
Hiring Organization: Rose International
Position Number: 504881
Industry: Medical Equipment & Supplies
Job Title: Staff Product Transfer Project Engineer
Job Location: Franklin, TN, USA, 37064
Work Model: Hybrid
Work Model Details: 3 Days onsite, 2 days remote
Shift: 8 AM - 5 PM CST Mon - Fri
Employment Type: Temporary
FT/PT: Full-Time
Estimated Duration (In months): 6
Min Hourly Rate($): 55.00
Max Hourly Rate($): 60.00
Must Have Skills/Attributes: Engineering, GMP, Manufacturing
Experience Desired: Experience in leading end-to-end biologics technology transfer projects (4 yrs); Strong regulatory experience supporting BLA submissions, post-approval manufacturing changes (4 yrs); Background working within global pharmaceutical, biotechnology, or biologics manufacturing (4 yrs)
Required Minimum Education: Bachelor’s Degree
Preferred Education: Master’s Degree
**C2C is not available**
Job Description
Required Education:
• Bachelor’s Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or Engineering
Preferred Education:
• Master’s Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or Engineering
Required Skills:
• Strong understanding of biologics manufacturing, upstream and downstream bioprocessing, sterile manufacturing, single-use systems, protein formulation, stability, and analytical methods.
• Working knowledge of FDA, EMA, ICH, cGMP requirements, process validation lifecycle, regulatory submissions, and post-approval manufacturing changes.
• Excellent project management, technical writing, communication, organizational, and stakeholder-influence skills in highly regulated environments.
• Minimum 4 years supporting technology transfer, manufacturing engineering, process engineering, validation, or scale-up in FDA-regulated cGMP environments.
• Experience working with Contract Manufacturing Organization (CMOs) and scientific leadership experience in GMP biologics manufacturing are preferred.
Responsibilities:
• Lead end-to-end bioprocess technology transfer activities, including process adaptation, scale-up, equipment qualification, validation, and commercial readiness.
• Serve as the primary engineering liaison between external manufacturing partners and internal Technical Operations, Regulatory Affairs, Quality, Manufacturing, Supply Chain, and Validation teams.
• Collaborate with internal cross-functional teams and external partners to lead technical discussions, resolve issues, communicate project status, risks, and recommendations to leadership, and ensure successful execution of transfer activities.
• 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 transfers 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.
- **Only those lawfully authorized to work in the designated country associated with the position will be considered.**
- **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**
Benefits:
For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.
California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.
If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.
Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).
Any time I did have a question and called, the phone was always answered, and my question/concern was immediately resolved.
Sally, Consultant
I believe the best thing that Rose HR has going for it is the incredible responsiveness. Everyone is very quick to reply to any concerns, and contacts the contracted employees very quickly and efficiently.
Kevin, Consultant
I have been very pleased with my experience with Rose International. Everyone that I encountered was very helpful and courteous.
Stephanie, Consultant
Rose International was not only attentive and responsive, but they were very professional and helpful whenever I called or needed any assistance.
Diane, Consultant
It is a great pleasure being a part of the Rose International Team.
Toni, Consultant
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