Combination Product Senior Development Engineer

Job description

This position will be part of BTx Pharmaceutical Research & Development located at Cambridge, UK. The incumbent will lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle. They will interact with cross functional development teams working with all levels of employees. ROLE RESPONSIBILITIES Ensures that combination product development activities are compliant with quality and regulatory standards – both internal and external. 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. Provide input and support for design validation, including but not limited to human factors engineering assessments. Support the generation of all regulatory submission data and content for assigned device projects. 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 internal and external audits of the DPDD Quality System. Identify, communicate, and develop strategies to improve combination product systems. BASIC QUALIFICATIONS BS degree in appropriate Science & Engineering discipline (Chemistry, Biochemistry; Biomedical, Mechanical, Materials, Chemical Engineering; or other related discipline) with extensive relevant experience in the Pharmaceutical Combination Product and/or Device industries. Thorough working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, ISO 11040 and the EU Medical Devices Directive. Working knowledge of EN 62366 and EU Medical Devices Regulation. 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) PREFERRED QUALIFICATIONS Knowledge of current US and global Regulations, FDA and ICH guidance, ISO standards for syringes/injectors, luer connectors, and quality system regulations (Part 4) for combination products Experience in Design Controls for Combinations Products Device Risk Management expertise. Understand statistical sampling plan and statistical analysis of test results. Familiar with Human Factors Engineering - Usability Engineering. Understand project management methodologies and capable to provide technical leadership for projects. Familiar with device assembling manufacturing process. Ability to perform mathematical calculations and ability to perform complex data analysis. Work Location Assignment: On Premise Purpose Breakthroughs that change patients' lives ... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience. Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation! Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. DisAbility Confident We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here! To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers . Research and Development