ppPerkinElmer's OneSource team is looking for a Validation Compliance Engineer to support production environment on the Customer site (MSD) in Schachen. More information about PerkinElmer and our business : PerkinElmer | Science with Purpose More information about our OneSource services: OneSource Laboratory Solutions | PerkinElmer Hybrid working model /p h3Responsibilities /h3 ul liPerforms the review and validation of test and data analysis equipment and systems used for phase 1 and phase 2 manufacturing. /li liMaintains all documentation pertaining to maintenance and qualification/calibration, both original and electronic records into Customer systems. /li liMay contribute to developing procedures and/or protocols. /li liServes as information resource for validation technicians, contractors and vendors. /li liContribute with Customer QA and Technical Unit in developing and implementing new specifications. /li liContribute to change management and deviation tracking processes, including leading or contributing to CAPA. /li /ul h3Requirements /h3 ul liBachelor’s degree in Life Sciences or Quality/Compliance discipline or equivalent experience preferred. /li li3 to 5 years of relevant experience in a (Bio-)Pharma company in quality, validation or compliance roles /li liKnowledge of cGMP, Annex 1 and validation regulations and requirements. /li liKnowledge of GMP, GLP, GDocP, pharmacopeia and regulatory requirements preferred. /li liDeveloped Customer service mindset /li liBe passionate about detail and tech aspects /li liStrong written and verbal communication skills in English, German language knowledge will be beneficial. /li liAbility to work both independently and as a team member /li liFollowing customer SOPs and regulatory guidelines FDA, EU SwissMedic /li /ul h3Join our Team! /h3 pWe are strongly committed to the development of your career and giving you opportunities to learn and grow. We make a difference for you while you make a difference in the world! /p /p #J-18808-Ljbffr
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Validation & Compliance Engineer • schachen, luzern, Switzerland