BIOPHARMA SERVICES in Cambridge

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate.

Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies.

Eurofins PSS Insourcing Solutions® is a global, award-winning insourcing solution. We place our skilled team directly at the client site, managing operations seamlessly and eliminating complexities. We ensure a strategic, long-term service commitment that delivers value directly at the client’s site, utilising their facilities, equipment, and methodologies, while maintaining the same service, expertise, and cGMP compliance available at the Eurofins facility.

This is a full time, permanent position. Working a flexible 37 hour week, Monday – Friday. The purpose of this job within the Device Engineering group is to support the design control and risk management subject matter expertise application to medical device and combination product development programmes throughout the product lifecycle.

Job Responsibilities:

• Lead design control and risk management activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
• Support and facilitation of effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
• Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external.
• Provide input and support to design validation including, but not limited to, human factors engineering assessments.
• Support the assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures to support device development and supply.
• Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
• Support the generation of all regulatory submission data and content for assigned device projects.
• Support internal and external audits of the client’s DCoE Quality Management System.
• Identify, communicate, and develop strategies to improve combination product systems.
• Contribute to systems based limited duration teams across client organisation.

Qualifications:

• Hold either a BSc, MSc or PhD in an appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline).
• Hold relevant experience in the pharmaceutical combination product and/or device industries.
• History of working in accordance with the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
• Experience in design controls for combination products.
• Experience of device risk management expertise.
• Familiar with Human Factors Engineering - Usability Engineering.
• Understand project management methodologies and capable to provide technical leadership for projects.
• Familiar with device assembling manufacturing processes.
• Ability to perform complex data analysis.
• Thorough working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
• Working knowledge of EN 62366, EN 60601, and EN 62304.
• Able to learn and apply established procedures in a reliable and consistent manner.
• Capable of working independently with minimal supervision.
• High level of attention to technical details and accuracy.
• Able to prioritize multiple responsibilities and to work on multiple tasks simultaneously.
• Able to work collaboratively in cross functional teams.
• Excellent communication (e.g., oral, written, presentation) and interpersonal relationship skills.
• Proficiency in general computer software such as word processing, spreadsheets, presentations.
• Understand Good Manufacturing Practices (GMP).

At Eurofins we are growing, innovating and always learning. We celebrate the achievements of our employees through annual long service awards, recognise our colleagues special life events, and we are committed to charitable causes through global fundraising activities.

As a Eurofins employee you will benefit from:

• Reward and Recognition
• Health Cash Plan
• Life Assurance (4 times annual salary).
• Company Pension Plan
• Employee Assistance Programme – 24/7 confidential support.
• Free car parking
• Worldwide career opportunities
• Access to Perkbox, allowing you to save money all year round.

Our people are the backbone of what we do, so it’s incredibly important we find the right individuals to join us. As a potential new recruit you’ll be invited to meet the team in the form of an assessment centre or a staged interview process dependent on the role and its requirements.

Your data: As part of any recruitment process, the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations.

Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique.

Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives.