Senior Device Assembly & Packaging Engineer - GMP

Lead Candidate Ltd; Fishers (IN); Presencial; USD 90.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

PTO & Holidays

401(k) plan with company match

Health & wellness plans

FSA and HSA programs

Descripción de la vacante

INCOG, a world-class CDMO for parenteral injectable drugs, seeks a TSMS Device Assembly and Packaging Engineer to support packaging development from clinical through commercial manufacture. The role emphasizes cross‑functional collaboration, technical transfer, and robust device assembly processes.

The candidate will ensure compliance with CGMPs, participate in regulatory considerations (FDA 21 CFR Part 4, ISO 13485), and contribute to process verification and continuous improvement.

Formación

• Bachelor’s degree in science, engineering or packaging technology.
• Master’s degree preferred.
• Experience in pharmaceutical packaging or combination product development.
• Knowledge of CGMPs for Combination Products and FDA guidance.

Responsabilidades

• Execute early packaging and device assembly development in cross‑functional teams.
• Develop technical documentation: Technical Transfer Plan, PFDs, Gap Assessments, Summary Reports, FMEA.
• Support root cause analysis and CAPA for packaging issues.
• Develop packaging/labeling material selection, qualification, and process implementation.

Conocimientos

GMP experience

Pharmaceutical packaging

Device assembly

Technical Transfer

Regulatory guidelines

Educación

Bachelor’s degree in science/engineering/packaging technology

Master’s degree in science/engineering/packaging technology

Descripción del empleo

INCOG, a world-class CDMO for parenteral injectable drugs, seeks a TSMS Device Assembly and Packaging Engineer to support packaging development from clinical through commercial manufacture. The role emphasizes cross‑functional collaboration, technical transfer, and robust device assembly processes.

The candidate will ensure compliance with CGMPs, participate in regulatory considerations (FDA 21 CFR Part 4, ISO 13485), and contribute to process verification and continuous improvement.