At a Glance
- Tasks: Lead design control projects for innovative combination products in a collaborative environment.
- Company: Join Pfizer, a leader in pharmaceutical research and development.
- Benefits: Enjoy flexible work culture, competitive salary, and opportunities for professional growth.
- Other info: Diverse and inclusive workplace committed to employee empowerment and career support.
- Why this job: Make a real impact on patients' lives through groundbreaking product development.
- Qualifications: BS degree in relevant science or engineering with experience in combination products.
The predicted salary is between 51750 - 63250 £ per year.
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!
Combination Product Senior Development Engineer in Cambridge employer: Pfizer
At Pfizer, we pride ourselves on being an exceptional employer, offering a dynamic and inclusive work culture that prioritises employee well-being and professional growth. Our hybrid work model fosters flexibility, allowing you to balance your personal and professional life while contributing to groundbreaking advancements in healthcare. With a commitment to diversity and a focus on empowering our employees, you'll find meaningful opportunities to make a real impact in the lives of patients around the world.
StudySmarter Expert Advice🤫
We think this is how you could land Combination Product Senior Development Engineer in Cambridge
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Pfizer. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Pfizer.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Pfizer. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Pfizer is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Combination Product Senior Development Engineer in Cambridge
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Pfizer!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Pfizer that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Pfizer!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Pfizer, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Pfizer
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Pfizer that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Pfizer’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
