QC Instrumentation Specialist – SK biotek Ireland

ABOUT US? SK biotek Ireland, an SK pharmteco company, is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part of the wider SK Inc. with revenues of $88 billion in . Our mission is to ‘make what matters for a healthy, happier world’, from grams to tonnes. The Swords Campus has led the way in the development, scale-up and commercial manufacture of Active Pharmaceuticals Ingredients (APIs), Highly Potent Active PharmaceuticalsIngredients and Chemical Intermediates for almost 60 years. With a talented workforce, exceptional technical capabilities, and facilities we have made some of the world’s most important medicines and continue to do so. Further information on SK pharmteco can be found at Current Need:SK biotek Ireland is seeking to recruit a Quality Instrumentation Specialist to join the QC Department. This position is in the Instrumentation group in QC Department.Position Description:Reporting to the QC Team Lead, the successful candidate will manage and control the laboratory instrumentation calibration and unplanned maintenance programme for the QC department. The role will involve.➢ Troubleshooting laboratory equipment➢ Review of all calibration/qualification documentation.➢ Liaising with Agilent to co-ordinate the calibration schedule➢ Liaising with the IM and QA department on equipment projects.➢ Provide QC analysts with support in Vaisala Temperature Data Logging System, Sample Manager and Empower.➢ Drive improvement initiatives in Sample Manager and Empower.➢ Review all Laboratory Calibration/Qualification documentation.➢ Review all equipment unplanned maintenance reports.➢ Manage changes to instruments, instrument relocations and decommissioning of instruments.➢ Manage the purchase of new instruments and related installation operation qualification reports that are required.➢ Manage laboratory instrument change controls.➢ Ensure equipment procedures are up to date.➢ Conduct all instrumentation calibration investigations.Minimum Requirements:Experience of regulatory agency audits and an understanding of laboratory GMP’s FDA regulations and their application to API manufacturing. The successful candidate will be required to prepare for and participate in Regulatory and Customer audits.Experience in Equipment Validation and the change control procedures is desirable.The successful candidate will have a strong ability to manage their own workload, and will interact with QA, IT, Supply Chain and with multiple vendors. Experience in Operational Excellence, 5s, Lean Labs, yellow belt certification and yellow belt projects is desirable.A BSc in Analytical Science, Chemistry or a related discipline is required. A minimum of 3 years’ experience working in the pharmaceutical industry is required. The desired candidate should be highly motivated, have strong teamwork skills, with proven success of working in a team environment.Why choose a career at SK biotek? A career with purpose and a chance to work with a world-leader in contract development and manufacturing in a fast-paced, dynamic, and growing organisation. Here at SK biotek Ireland, we believe we enhance patient’s lives and we need you! It reminds each one of us that what we do matters, and our mission is to ‘make what matters for a healthy, happier world’ – whatever your title, whatever your role, you act as a catalyst in a chain of events that helps millions of people all over the globe.By choosing a career with SK biotek Ireland, you’ll join a team of passionate people working together to improve lives by making what matters for a healthy, happier world.Other Benefits include:• Excellent opportunities for career enhancement and personal development• Competitive base salary• Annual bonus linked to business results.• A well-established further education program.• Pension scheme• Private Healthcare