Who are we?

Teva is a global pharmaceutical leader and the world's largest generic medicines producer committed to improving health and increasing access to quality Health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development, and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Curious and experienced device engineer to join MS&T team focused on (1) troubleshooting, commercialization, managing changes and regulatory challenges, (2) identification of next-wave technologies to support future portfolio and (3) technology exploration / assessment projects in alignment with company strategy and specific pipeline needs. He/she shall have the curiosity and drive to ideate and develop innovative solutions to fit core device strategies.

Additionally, candidate identifies, analyzes and suggests corrective actions to optimize procedures, processes, materials, technology and regulatory compliance issues. Provides direction and training to other staff, technicians and manufacturing operators.

ESSENTIAL AREAS OF RESPONSIBILITY

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• Provide technical leadership to support early device development projects while engaging with R&D, Primary packaging, Formulation and other Subject Matter Experts (SMEs).

• Lead efforts to evaluate and select appropriate device technologies for pipeline assets. Conduct feasibility / gap assessment in partnership with device engineering colleagues.

• Familiar with Quality by Design (QbD) principles and develop programs of work to build understanding of device designs and mechanisms. Conduct in-silico modelling to support device and mechanism understanding.

• Liaise with our internal and external manufacturing partners to assess early technology device Design for Manufacturability and Assembly (DFMA).

• Facilitate risk analysis (including risks identification, assessment and mitigation) for technologies under consideration, through complex computer simulation, lab testing programs and risk assessment tools

• Identify opportunities and propose potential mitigations during participation in design reviews at critical stages of device and product development.

• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.

Qualifications

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:

• Masters degree with 7+ years’ relevant experience OR PhD degree with 3+ years relevant experience
• Degrees in Pharmaceutical Sciences, Mechanical Engineering, Biomedical Engineering, Chemical Engineering or related field.
• Experience with development of drug-device combination (DDC) products and primary packaging
• Working experience of managing multiple projects of varying complexity simultaneously.
• Experience of using CAD and Simulation software
• Experience of working within device regulatory requirements and industry processes such as design controls (21 CFR 820.30), EU MDR 2017/745, risk management (ISO 14971), QMS (ISO 13485) and GMP.

Function

Sub Function

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