Senior Device Assembly and Packaging Engineer - Autoinjectors

INCOG BioPharma Services; Fishers (IN); In loco; USD 90.000 - 130.000; Tempo pieno

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Descrizione del lavoro

INCOG BioPharma Services in Fishers, IN seeks a Device Assembly and Packaging Engineer to support early packaging and device assembly development across tech transfer, process validation, GMP floor support, and continued process verification for clinical and commercial programs.

You will develop primary, secondary, and tertiary packaging, manage timelines from clinical to commercialization, and deliver robust, compliant packaging solutions for autoinjectors and complex systems.

Competenze

• Bachelor’s degree in science, engineering or packaging technology.
• Master’s degree in science, engineering or packaging technology preferred.
• Demonstrated experience in pharmaceutical packaging or combination product development and commercialization.
• Minimum 1 year of GMP experience.
• Experience with regulatory CGMPs for combination products and related guidelines (FDA/EU).
• Experience in Technical Transfer for pharmaceutical or related industry.

Mansioni

• Execute early packaging and device assembly development in cross-functional teams.
• Develop technical documentation: Technical Transfer Plan, PFD, Gap Assessments, reports, FMEA.
• Understand combination devices, packaging materials, and manufacturing processes.
• Troubleshoot packaging issues and support CAPA activities.
• Develop packaging/labeling material selection and qualification.
• Represent TSMS in project teams and communicate with customers.
• Author GMP manufacturing docs: Master Batch Records, BOMs, Processing Forms.
• Monitor process data and identify trends for improvement.
• Perform other related responsibilities as required.

Conoscenze

Device assembly

Packaging development

GMP knowledge

Technical transfer

Regulatory familiarity

Root cause analysis

Process validation

Formazione

Bachelor's degree in science or engineering

Master's degree preferred

Descrizione del lavoro

INCOG BioPharma Services in Fishers, IN seeks a Device Assembly and Packaging Engineer to support early packaging and device assembly development across tech transfer, process validation, GMP floor support, and continued process verification for clinical and commercial programs.

You will develop primary, secondary, and tertiary packaging, manage timelines from clinical to commercialization, and deliver robust, compliant packaging solutions for autoinjectors and complex systems.