Senior Technologist – Test Method Validation
Location: Witney, Oxfordshire
THE OPPORTUNITY:
With a track record of innovation and development, Abbott Diabetes Care designs, develops, and manufactures leading-edge glucose monitoring systems, for use in both home and hospital settings. We have a Global Centre of Excellence for Medical Devices based in Witney, Oxfordshire. The site manufactures significant volumes of test strips annually and has also been instrumental in the research, development, and manufacture of the next generation FreeStyle Libre Flash Glucose Monitoring System, launched in September 2014.
We have an exciting opportunity for a Senior Technologist – Test method Validation to join our Technical Services team supporting manufacturing at Witney, West Oxfordshire, with a particular focus around analytical test method validation.
Day-to-day, your work will be to lead on test method validation requirements, supporting the test method development of chromatographic methods (HPLC and GCMS) for analysis of residual solvents and APIs with hands on experience on laboratory equipment and instrumentation and controlling software. You will:
1. Have demonstrated laboratory experience on the methods, instrumentation and controlling software commonly used in HPLC, GC with UV and MS detection systems.
2. Create test method documents including SOPs, batch record, validation protocol, planning, execution and report writing
3. Ensure adherence to industry standards and regulatory guidelines (GLP).
4. Perform risk assessments, technical investigations and take corrective actions as needed.
5. Work with various teams to support other validation workstreams (software, equipment and process validations).
6. Keep detailed records and completing documentation of test method validation activities.
7. Lab instrument Software validation, change control and configuration / administration activities. Sound knowledge of 21CFR part 11 requirements (audit trail, electronic records and signatures).
ABOUT YOU:
To be successful, you will have a minimum of bachelor’s degree in a scientific subject and will bring prior analytical lab and test method Validation (TMV) experience. You must have excellent attention to detail skills, a logical and methodical approach to problem solving, the ability to prioritise and manage projects, and the flexibility to adapt to changing circumstances or new demands. A lot of your work will involve cross-functional teams, so you’ll also need the communication and inter-personal skills to be able to build relationships with colleagues in various departments across the business. You’ll need to enjoy interpreting data and writing reports, as a lot of your work will involve analysing results and making recommendations on material selection or test method development.
You will be expected to spend time in the manufacturing facility, so will need to have, or be able to develop, good hands-on practical skills. Good IT skills including Excel and PowerPoint are also required for this role.
WHY ABBOTT?
Abbott offers a benefits platform that provides security to you and your family.As you’d expect from an innovative global health care company, we offer an excellent range of benefits including competitive salaries, a defined contribution pension scheme, share ownership scheme, private healthcare, life assurance, and a flexible benefits schemewhich you can tailor to your own requirements.Here at Witney, we also like to help our employees live life to the fullest, and therefore we offer a range of optional initiatives for you to get involved in, including onsite allotments, couch to 5k campaigns, bee keeping, yoga and more!