Device & Packaging Senior Expert Engineering

Novartis; Basel; On-site; CHF 94,000 - 174,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid working options

Job summary

Novartis AG in Basel, Switzerland, onsite role focused on the technical development of packaging and delivery systems for new oral drugs, from early phase to commercialization and scale-up. Strong background in pharmaceutical packaging and medical device development is essential, with fluency in English and knowledge of regulatory requirements.

The role involves project planning, collaboration with development partners, risk management, documentation, and cross-functional support for regulatory

Qualifications

• Bachelor's or Master's degree in Packaging Science/Engineering or Mechanical Engineering or University level Engineering education.
• 7+ years experience in supporting or leading pharmaceutical packaging or drug delivery device development technical teams.
• Fluency in English language is required. Proficiency in German/French advantageous.
• Experience in development and writing of technical documentation and Design Control processes; regulatory, QA and GMP aspects.
• Mechanical/Industrial engineering in general Product design/Design for manufacture; test and verification methods.

Responsibilities

• Thorough project planning and definition of product requirements for oral packaging and drug delivery systems.
• Coordinate manufacturing process development and scale-up for clinical and production material.
• Lead and document technical work, risk management, and human factors engineering activities.
• Support cross-functional teams with regulatory dossier development and technical risk reviews.
• Transfer of Design History File to production and ensure high-quality documentation.

Education

Bachelor's or Master's degree in Packaging Science/Engineering or Mechanical Engineering

Job description

Salary Range

CHF93,800.00 - CHF174,200.00

Job Description Summary

Location: Basel, Switzerland #onsite

Role Purpose

The successful candidate for this position will need to be able to support the technical development of packaging and delivery systems for new oral drugs within the Novartis Oral Packaging & Delivery Systems Group, from early phase activities up to commercialization and production scale up. In addition to outstanding inter-personal skills, a strong technical background in pharmaceutical packaging and drug delivery medical devices is crucial to be able to support, monitor and challenge internal and external development partners.

Job Description

Tasks and responsibilities would typically include:

• Thorough project planning
• Supporting the definition of product requirements and qualification of oral packaging and drug delivery systems, e.g. drug/device combination products and medical devices
• Supporting the collaboration with other development business partners: Monitor work progress according to plan,
• Monitor, support and challenge technical development as well as test and verification work,
• Monitor development and implementation of manufacturing processes,
• Providing primary packaging and device expertise in a broader cross-functional drug product development team,
• Evaluating and challenging technical solutions,
• Supporting and coordinating the manufacturing of clinical material and the production scale up,
• Supporting cross functional project teams in the development, review and submission of regulatory dossiers,
• Leading Risk management activities,
• Managing and monitoring Human Factors Engineering activities,
• Monitoring of design verification activities (in-house),
• Leading and authoring technical documentation,
• Ensuring a high-quality Design History file,
• Transfer of Design History File to production.

Requirements

• Bachelor's or Master's degree in Packaging Science/Engineering or Mechanical Engineering or University level Engineering education.
• An ideal candidate would have a relevant degree in engineering and at least 7 years' experience in supporting or leading pharmaceutical packaging or drug delivery device development technical teams.
• Fluency in English language is required. Proficiency in German/French advantageous.
• Experience desire d
• Good understanding of pharmaceutical development in general,
• Experience in supporting complex projects / programs,
• Understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive, EU Medical Device Regulation),
• Development and writing of technical documentation of drug/device combination products and medical devices, including Design Control process and other applicable Regulatory, QA and GMP aspects,
• Mechanical/Industrial engineering in general Product design/Design for manufacture
• Test and verification, incl. development of methods and equipment
• General understanding of Human Factors Engineering, risk management and clinical studies processes and requirements,
• Good communication and conflict solving skills.

Benefits & Rewards

At Novartis, we're committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role: CHF93,800 to CHF174,200

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs.

In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.