The roleWe are currently looking for a Computerised Systems Validation (CSV) Engineer to join our global Digital Technology team to undertake validation activities that underpin and support the core growth pillars of the Douglas organisation.Ultimately, as a CSV Engineer, you would be responsible for ongoing Computerised Systems Validation / Computer Software Assurance (CSV/CSA) activities, providing technical and methodology support to ensure our ongoing compliance with GMP regulations. You would also collaborate in the development and improvement of CSV and data integrity processes.This is an exciting and broad role for the right candidate to be able to get their teeth into the CSV work we are doing here.You will be/haveMinimum of 5 years' experience implementing CSV solutions in a pharmaceutical manufacturer, medical device or related industry.Strong verbal, written and interpersonal communication skills.Experience in Technical Report writing including validation plans, validation reports and test reports.Proven critical thinking and problem-solving skills.Advanced levels of skill in the full MS suite of applications.A BEng / BSc or equivalent Qualification.Technical and professional knowledge of PIC/S Annex 11, 21 CFR Part 11, ISPE GAMP 5 principles and data integrity.A proven track record with automating manual data processes and moving from localised network / data storage to cloud-based solutions.About usDouglas Pharmaceuticals is one of New Zealand's healthcare success stories starting from humble beginnings in West Auckland over 50 years ago to having an ever-expanding footprint in local and global markets. We're working to develop, trial, manufacture, test, pack and distribute the best medicines, nutraceuticals and products to over 40 countries.At Douglas there are around 650 of us - including top scientists, researchers, manufacturers, regulators and engineers, and together we're on a mission to make high quality, effective and accessible products, for people who need it. We are here to do our life's best work.We're helping people with conditions like depression, schizophrenia, breast cancer, heart failure, and severe acne, as well as people who need antibiotics and medicines to support their immune systems.What we offerBe a part of an exciting growth journey in an organisation that values its people.Belong to a great team that looks for meaning and impact in all we do.Enjoy the flexi-work options.Learn on the job and through professional development opportunities.All applicants must undergo pre-employment screening and background checks.Next stepsIf you're invited to complete a video interview as the next stage of your application, we'd love you to embrace it. Video interviews allow more people the opportunity to demonstrate their abilities to the hiring manager in a new and innovative way, giving you a better chance of securing your ideal role. Relax, be yourself and don't worry, we all feel a bit awkward in front of the camera.If you are keen to be part of a true kiwi success story,apply today!Job Details:Reference13774ExpertiseHelp Desk & IT Support, Quality AssuranceJob LevelExperiencedLocationWest AucklandWork TypePermanent full-timeApplication Closes19 Jan 2025 23:55
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