For Us, It’s A Mission
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership.
Our Global Device Development organisation is focused on the design, development and commercialisation of a diverse portfolio of device technology solutions to enable delivery of our large and growing range of generic and branded products around the globe. The technologies we develop enable drug-delivery for respiratory, biologic, biosimilar and injectable products, and we work across Mylan to support innovative technology solutions to deliver healthcare to our patients. We operate from 4 sites: Dublin, Ireland, Cambridge & Sandwich, UK and Southpointe, Pittsburgh, USA. Every member of our team is dedicated to creating better health for a better world, one person at a time.
Make a Difference
We are seeking a talented Device Analyst to join the growing team. The successful candidate will support the development of medical devices and combination products across the Mylan portfolio. The role will be based in Sandwich, Kent, UK.
The successful candidate will:
- Performs mechanical and functional testing on medical devices and combination products using standard and bespoke techniques developed to meet requirements of device testing strategy.
- Develop Design Verification test plans in line with ISO 11608 and ISO 11040 and other relevant regulatory guidelines. Participate in design reviews throughout the device product lifecycle by identifying and addressing any analytical gaps and providing technical expertise to the project lead. Ensure all technical issues encountered are discussed with the relevant SMEs within the design and development group
- Review and interpretation of analytical data in line with study and protocol objectives. Compilation of technical reports to support design and development lifecycle
- Represent the device and product performance group on cross functional teams both internally within GDD to support design control on a range of device programs.
- Work with external laboratories to ensure study protocols are executed in line with GDD requirements including quality and regulatory requirements
- Authoring and/or review of protocols, technical reports, SOPs, analytical test methods and specifications.
- Performing device investigations and participate in GDD and technical investigation teams as required. Reporting and logging of aberrant results using Trackwise™. Troubleshoot instrumentation and investigate aberrant sample results.
- Maintaining a high standard of GMP in line with the GDD QMS ensuring audit readiness at all times.
- Attending EHS training and maintaining responsibility for adhering to appropriate EHS procedures. Ensure the appropriate risk assessments are in place to perform required tasks.
- In agreement with his/her supervisor organise his/her schedule based on relevant project Design and Development Plans and Device Testing Plans. Planning his/her own work to consistently achieve output of high quality results in a timely manner.
Make Our Values Your Values
Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the qualifications for this position:
- Degree in Analytical Chemistry/Chemistry/Biochemistry or equivalent, with some experience in industry
- GMP knowledge
- Experienced in technical report writing.
- Proven track record of analytical laboratory experience in GxP environment
- Experience in industry
- Mechanical/device testing
- Experienced in testing of inhalation products and in particular NGI, ED testing
- Experienced user of HPLC/UPLC
- Experienced in analytical testing of active pharmaceutical ingredients and/or drug product
- Experience in testing requirements for medical devices and/or combination products
- Be able to operate collaboratively across the Mylan Global Device Development organisation (i.e. not in isolation) to achieve clear goals and outcomes to advance the organisation.
- Be able to network with other groups across the Mylan organisation.
- Be prepared for occasional business travel/willingness to travel.
If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 35,000 worldwide, we can make a difference. We encourage you to visit Mylan.com to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care. Mylan is an Equal Opportunity Employer
To submit your application, please submit your CV and covering letter to email@example.com – stating “Device Analyst – Contractor” in the subject line.