INCOG BioPharma Services · 3 months ago
Principal Device Assembly & Packaging Engineer
Fishers, IN
Full-time
Onsite
Senior Level, Lead/Staff
5+ years expINCOG BioPharma Services is seeking a Principal Device Assembly and Packaging Engineer to lead complex device assembly and packaging development. The role focuses on ensuring robust and reliable processes for autoinjectors and complex packaging systems from clinical to commercial manufacturing.
BiopharmaBiotechnologyManufacturingPharmaceutical
Responsibilities
Lead execution of complex packaging and/or device assembly development activities in cross-functional teams with advanced pharmaceutical packaging and combination product development knowledge. Responsible for leading the development of primary, secondary, and tertiary packaging while managing multiple due dates and project timelines from clinical to commercialization across multiple programs
Lead client team meetings to understand complex packaging requirements and independently develop comprehensive technical documentation such as Technical Transfer Plan, Process Flow Diagrams (PFD), Gap Assessment, Summary Reports and Process FMEA
Demonstrate advanced understanding of combination devices (auto injectors), packaging materials and manufacturing processes with expertise in global packaging standards for pharmaceutical drug products, parenteral container-closure systems, and combination products
Lead technical troubleshooting and investigations of complex packaging issues to support comprehensive root cause analysis, product impact assessment and effective corrective and preventive actions
Provide advanced technical expertise for developing packaging/labeling material selection, qualification, and process implementation for new product programs with strategic impact
Serves as senior TSMS representative in project teams and manages direct communications with customers. Recognized as Subject Matter Expert for device assembly and packaging processes across multiple product lines
Lead authoring of complex GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms for multiple programs
Monitor and analyze Process Data across multiple packaging operations, identify trends and implement corrective actions independently
Lead cross-functional teams in assessing and implementing new packaging technologies and device assembly equipment
Conduct comprehensive impact assessments of changes to packaging materials, device components, and assembly processes
Mentor Entry Level engineers and provide technical training on device assembly and packaging best practices
Other responsibilities as required
Qualification
Required
Bachelor's degree in science, engineering or packaging technology required
5+ years of demonstrated experience in pharmaceutical packaging or combination product development and commercialization
Strong understanding of regulatory device requirements (DHF, RMF, Design Inputs, Design Outputs, Design Transfer)
Proven experience in Technical Transfer leadership for pharmaceutical or related industry
Advanced project management skills with ability to manage multiple complex programs
Excellent communication skills for client interaction and cross-functional team leadership
Preferred
Master's degree in science, engineering or packaging technology preferred
Advanced experience in global product launches and the associated CMC regulatory requirements
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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