Harba Solutions Inc.
Consultant - Engineering Specialist | Harba Solutions Indianapolis
Description
The Senior Tech Transfer Engineer will play a pivotal role in supporting all aspects of technology transfer, process validation, GMP floor operations, and continued process verification in alignment with current Good Manufacturing Practices (cGMP) for both clinical and commercial programs. This position provides critical technical oversight to ensure production processes are robust, scalable, and reliable, while serving as a key link between development and full‑scale manufacturing.
The Senior Tech Transfer Engineer will be responsible for scaling up and transferring processes based on internally generated or client‑provided data, partnering closely with cross‑functional teams to establish efficient and compliant operations. By combining hands‑on GMP support with technical leadership in validation and ongoing process verification, this role offers the opportunity to directly influence manufacturing success and deliver high‑quality products to patients.
Job Responsibilities
Support technology transfer, process validation, floor support, and continued process verification for clinical and commercial manufacturing programs in alignment with cGMP requirements.
Oversee scale‑up and transfer of processes into full‑scale manufacturing using data from internal development or external clients.
Select appropriate equipment and single‑use components for GMP operations; generate technical documentation such as transfer plans, gap assessments, process flow diagrams, and risk analyses (e.g., FMEAs).
Represent Manufacturing Sciences/Technical Services in cross‑functional project teams; serve as a subject‑matter expert for production processes.
Author and maintain GMP manufacturing records, including master batch records, bills of materials, and process forms.
Monitor process data, identify trends, and recommend corrective actions as needed.
Lead troubleshooting efforts and investigations of process deviations, supporting root cause analysis, product impact assessments, and development of CAPAs.
Provide technical guidance to operations and validation teams during process qualification and ongoing verification activities.
Collaborate with internal groups to evaluate and implement new technologies for GMP manufacturing.
Assess and manage the impact of changes to products, processes, equipment, procedures, and materials.
Qualifications
Bachelor’s degree in a science or engineering discipline required.
Minimum 5 years’ experience in a GMP pharmaceutical or biopharmaceutical manufacturing environment.
Direct experience with technology transfer in a regulated industry required.
Strong knowledge of process validation, troubleshooting, and data analysis in GMP settings.
Master’s degree in science or engineering preferred.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Engineering, Manufacturing, and Product Management
Industries
Pharmaceutical Manufacturing
Medical Equipment Manufacturing
Health and Human Services
Base pay range $100,000.00/yr - $120,000.00/yr
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The Senior Tech Transfer Engineer will play a pivotal role in supporting all aspects of technology transfer, process validation, GMP floor operations, and continued process verification in alignment with current Good Manufacturing Practices (cGMP) for both clinical and commercial programs. This position provides critical technical oversight to ensure production processes are robust, scalable, and reliable, while serving as a key link between development and full‑scale manufacturing.
The Senior Tech Transfer Engineer will be responsible for scaling up and transferring processes based on internally generated or client‑provided data, partnering closely with cross‑functional teams to establish efficient and compliant operations. By combining hands‑on GMP support with technical leadership in validation and ongoing process verification, this role offers the opportunity to directly influence manufacturing success and deliver high‑quality products to patients.
Job Responsibilities
Support technology transfer, process validation, floor support, and continued process verification for clinical and commercial manufacturing programs in alignment with cGMP requirements.
Oversee scale‑up and transfer of processes into full‑scale manufacturing using data from internal development or external clients.
Select appropriate equipment and single‑use components for GMP operations; generate technical documentation such as transfer plans, gap assessments, process flow diagrams, and risk analyses (e.g., FMEAs).
Represent Manufacturing Sciences/Technical Services in cross‑functional project teams; serve as a subject‑matter expert for production processes.
Author and maintain GMP manufacturing records, including master batch records, bills of materials, and process forms.
Monitor process data, identify trends, and recommend corrective actions as needed.
Lead troubleshooting efforts and investigations of process deviations, supporting root cause analysis, product impact assessments, and development of CAPAs.
Provide technical guidance to operations and validation teams during process qualification and ongoing verification activities.
Collaborate with internal groups to evaluate and implement new technologies for GMP manufacturing.
Assess and manage the impact of changes to products, processes, equipment, procedures, and materials.
Qualifications
Bachelor’s degree in a science or engineering discipline required.
Minimum 5 years’ experience in a GMP pharmaceutical or biopharmaceutical manufacturing environment.
Direct experience with technology transfer in a regulated industry required.
Strong knowledge of process validation, troubleshooting, and data analysis in GMP settings.
Master’s degree in science or engineering preferred.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Engineering, Manufacturing, and Product Management
Industries
Pharmaceutical Manufacturing
Medical Equipment Manufacturing
Health and Human Services
Base pay range $100,000.00/yr - $120,000.00/yr
#J-18808-Ljbffr