Engineer - Instrument Management & Qualification – Neuchatel, Switzerland
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With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions.
It’s so rare in R&D that everything aligns to create the ideal conditions for outstanding work. Right now, at PMI, that’s exactly what’s happening. R&D is the driving force for our bold new vision: to replace cigarettes with a revolutionary portfolio of alternative products.
Join us and you’ll have the resources, support and technology you need to break new ground and see ideas come to life. You’ll be surrounded by some of the brightest scientists in their fields, with fast access to subject experts and commercial decision-makers.
If you’re creative, courageous and ready to take risks, you can make a huge impact and propel your career in an endless number of directions. Ultimately, by delivering our smoke-free and beyond nicotine future
Your ‘day to day’
As an Engineer - Instrument Management & Qualification, you will be responsible for leading the assets optimization as well as the qualification and maintenance of laboratory equipment/instruments for Non-Clinical Sciences (NCS) in Neuchatel. More precisely, you will drive Capex project related to instruments/equipment, lead the qualification of laboratory equipment/instruments, plan the laboratory equipment/instruments maintenance budget, optimize the maintenance strategy based on risk, coordinate suppliers activities on maintenance and qualification, act as specialist, adapt the processes and train personnel on instrument management and qualification. You will be the interface on these processes with the other departments to ensure proper alignment and optimization and will work according to Good Laboratory Practice (GLP) RS 813.112.1 Ordonnance sur les bonnes pratiques de laboratoire (OBPL) du 18 mai 2005 (Etat le 12 juillet 2005), ISO/IEC 17025, Good Clinical Laboratory Practice (GCLP), PMI global directives and procedures and study plans.
More specifically, you'll
Drive Non-Clinical Sciences Labs & Ops Capex projects in collaboration with Project Management Office, Procurement and Finance (initiate process, coordinate collection of information and ensure timely submission of accurate information) and ensure that instruments lifecycle (identification of needs, commissioning, qualification, maintenance, decommissioning) is carried out according to a defined schedule and relevant quality documentation. Whenever required, challenge the need of new equipment in the light of current equipment usage, business needs, and data management requirements.Support laboratory personnel in the laboratory equipment/instruments qualification. Write or review Initial Risk Assessments and User Requirement Specifications. Review of supplier’s instrument qualification documents. Write or review instrument qualification documentation as per PMI Quality Management System. Carry out instrument qualification tests if necessary. Act as specialist on instrument qualification for the department. Maintain yearly plan for the department for instrument qualification, including calibration, maintenance, and periodic review.Track usage of instruments (including maintenance activities) and up- and down-time to challenge asset investment and drive capacity improvement. Monitor progress of activities with involved parties to ensure that agreed achievements are met. Report and update corresponding budget (Capital and Project Expenses) related to new asset requests as per Finance standards.Maintain the Scientific Instrument Management System up to date in order to be used as input for asset management and maintenance budget planning. Function as administrator of the laboratory inventory database, specifically for the creation of new equipment, retirement of equipment and training of users.Consolidate Non-Clinical Science department needs for equipment maintenance and lead in collaboration with Procurement supplier assessment, contract negotiation and supplier performance management. Find opportunities of maintenance and spare parts budget optimization while ensuring compliance with applicable standards and procedures. Create new global Purchase Orders/contracts covering maintenance of groups of equipment. Where such PO/contract is already in place, challenge and optimize their content (increase amount of equipment in scope, potentially beyond Non-Clinical Sciences, update level of service). Plan and coordinate maintenance tasks with external suppliers and internal teams to achieve optimal costs as well as maximum availability and reliability of laboratory instruments.Develop, monitor, and control specific measurements & metrics related to asset management processes stability, identification of gaps, improvement potential and improvement trends, ensure that the relevant continuous improvement standards are implemented, and review/improve current processes and practices. The metrics to develop are: Equipment usage, Capex projects lead time and Maintenance budget optimization.
Who we’re looking for
Master’s (preferred) or Bachelor’s Degree in Science or Quality, or equivalent experience and skills.Minimum 3 years’ experience in a biology or chemistry laboratory, including minimum 2 years’ experience in quality, instrument qualification and/or instrument validation for the Life Sciences industry.Excellent planning and organizational skillsStrong relationship management while working with teams.Sound knowledge of ISO17025 and OECD Good Laboratory Practices.Good Knowledge of Computerized Systems Validation (e.g. GAMP 5, CFR 21 part 11).Fluency in English, both written and spoken is required.
What we offer
Our success depends on the people who come to work every single day with a sense of purpose and an appetite for progress.
Join PMI and you too can:
Seize the freedom to define your future and ours. We’ll empower you to take risks, experiment and explore.Be part of an inclusive, diverse culture, where everyone’s contribution is respected; collaborate with some of the world’s best people and feel like you belong.Pursue your ambitions and develop your skills with a global business – our staggering size and scale provides endless opportunities to progress.Take pride in delivering our promise to society: a smoke-free future.
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