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- Tasks: Lead validation activities for medical devices and ensure compliance with regulations.
- Company: Join Biocomposites, a global leader in innovative medical solutions.
- Benefits: Enjoy competitive salary, pension, discounts, and free travel options.
- Why this job: Make a real difference in healthcare by ensuring product safety and efficacy.
- Qualifications: 3+ years in validation within pharma/medical devices and strong communication skills.
- Other info: Be part of a diverse team that values growth and collaboration.
The predicted salary is between 36000 - 60000 £ per year.
Biocomposites is an international medical devices company that engineers, manufactures, and markets world leading products for use in infection management in bone and soft tissue. Based in Keele, UK, it has global operations across Europe, USA, Argentina, Canada, China, and India. Biocomposites is a world leader in the development of innovative calcium compounds and bone cements for surgical use. Its products regenerate bone and target infection risks across a variety of specialties, including musculoskeletal infection, orthopaedics, trauma, spine, foot and ankle, podiatry, and sports injuries. Biocomposites products are now used in over one million procedures per annum and sold in more than 100 countries around the world.
The Validation Engineer role will primarily be accountable for the validation for processes, facilities, equipment, computer software validations (CSV), in both medical device and pharmaceutical (cGMP) environments, including the Site Validation Master Plan (SVMP).
Duties & responsibilities:
- Maintain Site Validation Master Plans (SVMP), Summary Reports and other required documentation for a validation exercise.
- Organise and lead validation activities to provide an effective validation service.
- Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans, objectives and schedules.
- Provide validation support and advice to operations and other areas of the business as required to ensure that all operations are carried out in compliance with regulatory and company requirements.
- Ensure design projects relating to processes, facilities, equipment, and CSV validation are in compliance with regulatory and company requirements.
- Provide specialist knowledge on validation of; process, facility, equipment and application of computer software used within production and service.
- Promote effective working relationships and ensure they are maintained through the validation working party.
- Support a continuous improvement culture within the business.
- Develop work plans, assign tasks, and supervise teams to achieve the overall site validation requirements.
Role Requirements:
- Level 6 within a science regulated industry or relevant experience.
- Minimum 3 years Validation experience within Pharmaceutical/Medical Devices, including cleaning, analytical methods, lab equipment, computer system validation and re-qualification.
- Experience of creation of validation protocols and reports.
- Manufacturing process validation experience preferable, including the validation of new processes and changes to established processes using the lifecycle approach to validation.
- Proficient in Minitab or other alternative system and software packages.
- Knowledge of Quality Management Systems.
- Excellent communication skills.
- Ability to work to tight deadlines and high attention to detail.
What do we offer?
Competitive salary and benefits! With us, you will receive a competitive salary package and benefits.
We grow talent. At Biocomposites we create opportunities to thrive and grow.
One Biocomposites – team spirit & engagement. Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions.
Who do we look for?
- People who are passionate about what we do.
- People who are open minded to evolving the way we work.
- People who can work together to transform outcomes and change lives.
Benefits:
- Company events
- Company pension, life assurance, employee assistance programme
- Employee discount
- Free or subsidised travel
- Free on-site parking
Validations Engineer in London employer: Biocomposites
Contact Detail:
Biocomposites Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Validations Engineer in London
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect with current employees at Biocomposites. A friendly chat can sometimes lead to opportunities that aren’t even advertised!
✨Tip Number 2
Prepare for interviews by brushing up on your validation knowledge. Be ready to discuss your experience with processes, equipment, and software validations. Show them you’re not just a fit on paper but also in practice!
✨Tip Number 3
Don’t forget to showcase your soft skills! Communication and teamwork are key in this role. Share examples of how you’ve worked effectively with others to achieve common goals during your interviews.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re genuinely interested in being part of the Biocomposites team. Let’s get you that Validation Engineer role!
We think you need these skills to ace Validations Engineer in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Validation Engineer role. Highlight your relevant experience in validation processes, especially in medical devices or pharmaceuticals. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about working with us at Biocomposites and how your background makes you a perfect fit for the team. Keep it engaging and personal!
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements in previous roles. Whether it’s successful validation projects or improvements you’ve implemented, we love to see how you've made an impact!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Biocomposites
✨Know Your Validation Stuff
Make sure you brush up on your validation knowledge, especially in the context of medical devices and pharmaceuticals. Be ready to discuss your experience with cleaning, analytical methods, and computer system validation, as these are crucial for the role.
✨Showcase Your Project Management Skills
Since the role involves planning and leading validation activities, be prepared to share examples of how you've successfully managed projects in the past. Highlight your ability to meet deadlines and align with project objectives, as this will demonstrate your organisational skills.
✨Communicate Effectively
Excellent communication is key in this role. Practice articulating your thoughts clearly and concisely. Think about how you can convey complex validation concepts in a way that’s easy to understand, as you'll need to collaborate with various teams.
✨Emphasise Continuous Improvement
Biocomposites values a culture of continuous improvement. Be ready to discuss how you've contributed to process enhancements in your previous roles. Share specific examples of how you've identified areas for improvement and implemented changes that benefited the team or project.
