Scientist, Device & Product Performance (18 Month Fixed Term Contract)
Location: Sandwich, England, United Kingdom
Time Type: Full-time
Posted on: Yesterday
Job Requisition ID: R5652899
The Role & What You Will Be Doing
Every day, we rise to the challenge to make a difference and here’s how the Scientist (Device and Product Performance) will make an impact:
* Provision of technical expertise to support the development of Combination Products.
* Responsible for activities such as metrology testing, engineering verification, design verification, device functional stability, biological evaluation, method development, transport & shipping studies.
* Performing Development and Validation of Test Methods to support Design Verification Testing either to internal/external test facilities or manufacturing sites.
* Dealing with Viatris Affiliates and/or Third Partner Companies to support exhibit and registration batches, through review and implementation of controls and additional requirements if needed such as manufacturing investigations.
* Responsible for testing of combination products within the Global Device Development portfolio including generation of protocols, oversight of execution of testing at external test facilities and writing of reports.
* Trending and statistical analysis of analytical data including compilation of technical reports to support combination product development lifecycle.
* Ensuring that the Combination Product meets any requirements for reliability, through implementation of appropriate controls and assessment of the product against suitable specifications.
* Responsible for compilation and review of technical documentation within GDD in line with global regulatory requirements, guidance’s and the latest regulatory and industry thinking.
* Support of all R&D Lab activities including, Equipment calibration and Qualification, Documentation requirements, Trackwise records.
* Attending EHS training and maintaining responsibility for adhering to appropriate EHS procedures. Ensure the appropriate risk assessments are in place to perform required tasks.
* Support equipment qualifications, vendor calibrations and preventative maintenance in line with the laboratory qualification and preventative maintenance schedule as required.
* Lead general laboratory activities including; Procedure updates, generation of metrics, sample management, data review/verification, instrument daily calibrations, shipping of samples.
* Responsible for following all EHS process and procedures.
About Your Skills & Experience
For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
* Degree in Science/Engineering (Master’s preferred).
* 3+ years’ experience in pharmaceutical and/or medical device development.
* Experience in the development and validation of analytical methods.
* Experienced in application of statistical techniques for data analysis.
* Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage.
* Experience of writing and supporting regulatory submissions would be an advantage.
* Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks.
* Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholders.
* Some travel will be required as part of this role.
At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.
Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be.
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life.
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