Senior Device Manufacturing Engineer (m/f)

About us

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!

Your responsibilities

• Serve as technical leader for third party device manufacturing, device investigation and implementation of process solutions
• Actively participate in creation and review of risk management documents
• Participate in IQ/OQ/PQ activities including the drafting or review of protocols and validation reports
• Oversee Process Failure Modes and Effects Analysis (pFMEA), and Design for Manufacture (DFM) and Design for Assembly (DFA) activities
• Participate in selection and qualification of device CMOs
• Work with project leaders and both internal and external team members to ensure proper DFx for commercialization of new products
• Review documents to support in-line products including change controls, manufacturing investigations, CAPA implementation plans and effectiveness checks
• Create process and equipment documentation for improvements and initial installation
   

Your profile

• Master’s Degree in science, engineering, or technical field 
• Proven experience in the medical device and/or combination products field is mandatory
• Working experience of medical device GMP Quality Systems and related requirements 
• Previous experience with drug devices (syringes, auto-injectors, nasal sprays, transdermal patches, inhalers) 
• Medical device/combination product industrial and/or design control experience
• Previous experience supporting multi-site and multi-design device/combination product development teams along with Quality management system auditing experience is highly desirable
• Excellent interpersonal communication skills and the ability to navigate effectively within a cross-functional team environment
• Fluency in English is mandatory
• Readiness to travel if necessary 

Place of work / Location

• Zagreb (Croatia), Sofia (Bulgaria), Ulm (Germany) or Haarlem/Amsterdam (Netherlands) - depending on your residence. 
• Relocation support available

Reports To

Director, Third Party Operations EU

Already Working @TEVA?

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Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.