CSV Senior Quality Engineer
Hays AB / Övriga jobb / Stockholm
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hela Sverige About the Johnson & Johnson Medical Devices CompaniesJohnson & Johnson is a company committed to doing good for the world. We blend Heart, Science and Ingenuity to profoundly change the trajectory of health for humanity. The Johnson & Johnson Medical Devices Companies' purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopedics, cardiovascular and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide. Johnson & Johnson Medical Devices is currently $20 billion in worldwide sales. The business is expected to experience solid growth over the next 5 to 7 years. The site in Uppsala is a part of JnJ Surgical Vision and develops and manufactures the eye surgery product Healon which is distributed globally and sold in more the 70 countries worldwide. The footprint, land and premises, is about 22 000 m2 and the company employs about 150 people in Uppsala. The site will now strengthen the quality function by the recruitment of a:CSV Sr Quality EngineerThe Computer System Validation Senior Engineer will be our local champion in IT, production automation and laboratory system validation. You will perform validation of GMP relevant computer systems, in line with internal and external, global and local guidelines and regulations. Validation activities will also include preparing and executing protocols and preparing final reports for IQ, OQ and/or PQ of basic cell processing equipment. The ideal candidate exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. As CSV Sr Quality Engineer you will be a member of the Site Quality assurance and Quality system team.Objectives of the Position1. Manages multiple CSV projects of significant magnitude across various disciplines involving the use of Computerized Systems with latitude for action or decision. Utilizes a wide range of engineering principles and works with technical expertise, to lead validation activities. (50%)2. Provides leadership and guidance on CSV programs, principles, risk management, root cause analysis, statistics, quality systems and Good Engineering Practice (GEP) policies and procedures for facility, utilities, manufacturing process equipment and associated computerized (automated) systems and software (20%) 3. Contributes to the development and enhancement of software validation programs/policies and procedures for manufacturing equipment/process, programs/policies/procedures with respect to Revalidation, Commissioning & Qualification, Sampling Plans, Process Capability, Root Cause Analysis/Failure Investigations, and Risk Management. (20%)Proactively monitors and examines systems, processes, and standards to identify areas for review, improvement, change, or elimination. Establishes linkages to other quality 1. systems/programs like Technology Transfer, Change Management, Test Method Transfer, and CAPA. (10%)Qualifications required* Minimum Bachelor's Degree in Engineering or Computer science* A minimum of 5 years of experience with B.Sc. degree or a minimum of 3+ years with M.Sc. degree. * A minimum of 2 years' experience of Computerized System Validation in Pharmaceutical or Medical device industry.* Excellent communication, interpersonal, organizational and analytical skills.* Thorough knowledge, understanding and application of principles, concepts and practices of GAMP and GMP/ISO regulations such as Part 11 and Data integrity.* Excellent mentoring, coaching skills* Demonstrated leadership abilities.Preferred Skills and Experience:* Knowledge of automation system programing used in pharmaceutical/medical device manufacturing such as PLC's, Scada or DCS systems.* Knowledge of laboratory data systemPosition location is Uppsala, Sweden.To apply and get additional informationIn this recruitment Johnson & Johnson is working with Hays Life Sciences. If you're interested in this role, then apply with an up-to-date copy of your CV and personal letter in one document. For inquiries regarding the position or process please contact the responsible recruitment consultant Isolde Andersson (
isolde.andersson@hays.com). Selection of candidates will be carried out continuously, so be sure to send in your application as soon as possible.
Publiceringsdatum2019-05-09Så ansöker duSista dag att ansöka är 2019-05-27
Ange följande referens när du ansöker: CSV Senior Quality Engineer
FöretagHays AB
Jobbnummer 4777243
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