INCOG BioPharma Services · 5 hours ago
Packaging TSMS Engineer
Fishers, Indiana
Full-time
Onsite
Entry, Mid Level
1+ years expINCOG BioPharma Services is seeking a Packaging TSMS Engineer to support device assembly and packaging development. The role involves ensuring robust manufacturing processes and providing technical guidance throughout packaging and device assembly processes for clinical and commercial programs.
BiopharmaBiotechnologyManufacturingPharmaceutical
Responsibilities
TSMS Device Assembly and Packaging Engineer is responsible for the execution of early packaging and/or device assembly development activities in a cross-functional team and requires pharmaceutical packaging and combination product development knowledge. You will be responsible for the development of primary, secondary, and tertiary packaging while managing due dates and project timelines from clinical to commercialization
Meet with client team to understand packaging requirements and develop technical documentation such as Technical Transfer Plan, Process Flow Diagrams (PFD), Gap Assessment, Summary Reports and Process FMEA
A solid understanding of combination devices (auto injectors), packaging materials and manufacturing processes and experience in global packaging standards for pharmaceutical drug products, parenteral container-closure systems, and combination products is required
Assists technical troubleshooting and investigations of packaging issues to support root cause analysis, product impact assessment and effective corrective and preventive actions
Provide technical expertise for developing packaging/labeling material selection, qualification, and process implementation for new product programs
Represents TSMS in project teams and communicates directly with customers. Recognized as Subject Matter Expert for the device assembly and packaging processes
Help authoring GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms
Monitor Process Data, identify trends and propose actions as necessary
Other responsibilities as required
Qualification
Required
Bachelor's degree in science, engineering or packaging technology
Demonstrated experience in the field of pharmaceutical packaging or combination product development and commercialization
Experience in global product launches and the associated CMC regulatory requirements
Understanding of regulatory device requirements (DHF, RMF, Design Inputs, Design Outputs, Design Transfer)
Minimum 1 year of GMP experience required
Experience in Technical Transfer for pharmaceutical or related industry
Preferred
Master's degree in science, engineering or packaging technology
Company
INCOG BioPharma Services
Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$86.63M2024-05-29Series B· $42.86M
2022-05-10Undisclosed· $15M
2022-05-10Debt Financing
Leadership Team
Tedd Green
Co-founder & Chief Operating Officer
Recent News
Inside INdiana Business
2025-12-16
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