Senior Design Assurance EngineerSandoz UK & Ireland • Cambridge, England, United Kingdom
Senior Design Assurance Engineer
Sandoz UK & Ireland
- Cambridge, England, United Kingdom
- Cambridge, England, United Kingdom
À propos
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Senior Design Assurance Engineer
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Sandoz UK & Ireland . Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. Join us, the future is ours to shape. Key Responsibilities
Provide expertise in a range of design assurance activities, including risk management, HF/UE activities, verification and validation, and internal auditing. Act as senior DA Engineer within programs, providing strategic and technical oversight pertaining to DA Engineering. Provide support and development for junior colleagues, including mentorship within projects. Support the group leader to aid the smooth running of the department. Lead initiatives to improve the efficiency and effectiveness of the group. Lead or participate in design reviews. Assume specific program responsibilities (e.g., risk management team leader, design history file owner). Essential Requirements
Masters, PhD, or university degree in engineering, Quality, life sciences, or other relevant subject. Proven track record in development of medical devices (ideally in drug delivery) and/or combination products within pharmaceutical, medical devices, and/or combination products settings. Extensive technical knowledge of medical device technology and drug-device combination products. Proven ability to provide guidance and mentorship to junior engineers. High level of proficiency in multiple engineering areas: risk analysis (ISO 14971), HF/UE, specification setting, Good Documentation Practice, etc. Results-oriented, enthusiastic, and driven by excellence. Excellent command of English (verbal and written). Experience with ISO 13485 medical devices quality framework and knowledge of GMP, EU, and FDA regulatory requirements. You’ll Receive
Competitive salary Annual bonus Pension scheme Health insurance 24 days annual leave Flexible working arrangements Employee recognition scheme Learning and development opportunities Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz is a leader in this sector and provided more than 900 million patient treatments across 100+ countries in 2024. We aim to do more, through investments in development capabilities, production sites, acquisitions, and partnerships, to shape the future of Sandoz and improve patient access to affordable medicines. Our momentum is powered by an open, collaborative culture with an agile and collegiate environment and where diversity is welcomed and personal growth is supported. Commitment To Diversity & Inclusion
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. #Sandoz Job Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: Pharmaceutical Manufacturing
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Compétences linguistiques
- English
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