Device Assembly & Packaging Engineer

INCOG BioPharma Services • Fishers, IN

1d • Onsite

About The Position

The Technical Services and Manufacturing Sciences (TSMS) Device Assembly and Packaging Engineer will be responsible for supporting device assembly and packaging development across all facets of Tech transfer, Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing practices (cGMP) for clinical and commercial programs. This role will provide technical support for secondary manufacturing operations to ensure robust and reliable packaging and device assembly processes are established and executed.

This position will support the delivery of technical guidance and assistance throughout packaging and device assembly processes. The primary objective is to assist with establishing secondary manufacturing processes for autoinjectors and complex packaging systems that consistently deliver high-quality combination products from clinical through commercial manufacturing.

Requirements

• 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).
• Experience in Technical Transfer for pharmaceutical or related industry.
• Solid understanding of combination devices (auto injectors), packaging materials and manufacturing processes.
• Experience in global packaging standards for pharmaceutical drug products, parenteral container-closure systems, and combination products.

Nice To Haves

• Master’s degree in science, engineering or packaging technology.

Responsibilities

• Execution of early packaging and/or device assembly development activities in a cross-functional team, requiring pharmaceutical packaging and combination product development knowledge.
• Development of primary, secondary, and tertiary packaging while managing due dates and project timelines from clinical to commercialization.
• Meeting with client teams to understand packaging requirements and develop technical documentation such as Technical Transfer Plan, Process Flow Diagrams (PFD), Gap Assessment, Summary Reports and Process FMEA.
• Assisting with technical troubleshooting and investigations of packaging issues to support root cause analysis, product impact assessment and effective corrective and preventive actions.
• Providing technical expertise for developing packaging/labeling material selection, qualification, and process implementation for new product programs.
• Representing TSMS in project teams and communicating directly with customers, acting as a Subject Matter Expert for the device assembly and packaging processes.
• Authoring GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms.
• Monitoring Process Data, identifying trends and proposing actions as necessary.
• Other responsibilities as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level