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INCOG BioPharma Services · 2 months ago

Principal Packaging & Device Assembly Engineer

Fishers, Indiana

Full-time

Onsite

Senior Level, Lead/Staff

3+ years exp

INCOG BioPharma Services is seeking a Principal Packaging & Device Assembly Engineer to support all facets of Tech transfer, Process Validation, and GMP Floor Support. The role involves delivering technical guidance throughout the production process to ensure robust and reliable production processes for high-quality products.

BiopharmaBiotechnologyManufacturingPharmaceutical

Responsibilities

This TSMS 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

Have 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

Leads technical troubleshooting and investigations of packaging issues to support root cause analysis, product impact assessment and effective corrective and preventive actions

Provide technical guidance and oversight to Operations and Validation group to support Process Performance Qualification and Continuous Process Verification

Provide technical expertise for developing packaging/labeling material selection, qualification, and process implementation for new product programs

Author and review of regulatory information packages and filings/submissions

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

Demonstrate ability to engage and effectively influence both internal and external team members across cross-functional groups to prioritize work effectively in a dynamic environment

Monitor Process Data, identify trends and propose actions as necessary

Other responsibilities as required

Qualification

Pharmaceutical packagingDevice assemblyTechnical TransferGMP experienceProcess ValidationRoot cause analysisRegulatory submissionsCross-functional collaborationTechnical documentation

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

Minimum of 3 years 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.

Founded in 2020

Fishers, Indiana, USA

201-500 employees