Overview
Principal Engineer - Device & Packaging role at Real (Basel, Switzerland). Contract duration: 01/11/2025 - 31/10/2026. The role supports the technical development of packaging and delivery systems for new oral drug products—from early‑phase development through to commercialization and production scale‑up.
Responsibilities
* Thorough project planning
* Support the definition of product requirements and qualification of oral packaging and drug delivery systems (e.g. drug/device combination products and medical devices)
* Collaborate with other development partners: monitor progress, support and challenge technical development and verification work, and monitor manufacturing process development and implementation
* Provide primary packaging and device expertise within a cross‑functional drug product development team
* Evaluate and challenge technical solutions
* Coordinate manufacturing of clinical material and production scale‑up
* Support cross‑functional project teams in development, review and submission of regulatory dossiers
* Lead risk management activities
* Manage and monitor Human Factors Engineering activities
* Monitor design verification activities (in‑house)
* Lead and author technical documentation and ensure a high‑quality Design History File
* Transfer the Design History File to production
Qualifications
* Bachelor's or Master’s degree in Packaging Science/Engineering, Mechanical Engineering, or equivalent
* Minimum 7 years of experience in supporting or leading pharmaceutical packaging or drug delivery device development teams
* Fluency in English; German or French is advantageous
* Strong understanding of pharmaceutical development processes
* Experience in supporting complex projects/programs
* Solid knowledge of medical device regulations (FDA 21CFR 820, EU Medical Device Directive, EU Medical Device Regulation)
* Experience in developing and writing technical documentation for drug/device products and medical devices, including Design Control and regulatory, QA, and GMP aspects
* Background in mechanical/industrial engineering: product design/DFM, test and verification, and equipment development
* Understanding of Human Factors Engineering, risk management, and clinical study processes
* Strong communication and conflict resolution skills
Interested in learning more or applying?
Reach out for details or to submit your profile: s.keel(at)realstaffing.com
Location: Basel, Switzerland
Employment type: Temporary
Note: This job description reflects current requirements and may be subject to change.
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