Validation & Compliance Engineer

ph3Validation Compliance Engineer /h3 pPerkinElmer's OneSource team is looking for a bValidation Compliance Engineer /b to support bproduction environment /b on the Customer site (MSD) in Schachen. /p pMore information about PerkinElmer and our business : PerkinElmer | Science with Purpose (opens in new window) /p pMore information about our OneSource services: OneSource Laboratory Solutions | PerkinElmer (opens in new window) /p pHybrid working model /p pbResponsibilities: /b /p ul lipPerforms the review and validation of test and data analysis equipment and systems used for phase 1 and phase 2 manufacturing. /p /li lipMaintains all documentation pertaining to maintenance and qualification/calibration, both original and electronic records into Customer systems. /p /li lipMay contribute to developing procedures and/or protocols. /p /li lipServes as information resource for validation technicians, contractors and vendors. /p /li lipContribute with Customer QA and Technical Unit in developing and implementing new specifications. /p /li lipContribute to change management and deviation tracking processes, including leading or contributing to CAPA. /p /li /ul pbRequirements /b /p ul lipBachelor’s degree in Life Sciences or Quality/Compliance discipline or equivalent experience preferred. /p /li lip3 to 5 years of relevant experience in a (Bio-)Pharma company in quality, validation or compliance roles /p /li lipKnowledge of cGMP, bAnnex 1 /band validation regulations and requirements. /p /li lipKnowledge of GMP, GLP, GDocP, pharmacopeia and regulatory requirements preferred. /p /li lipDeveloped Customer service mindset /p /li lipBe passionate about detail and tech aspects /p /li lipStrong written and verbal communication skills in English, German language knowledge will be beneficial. /p /li lipAbility to work both independently and as a team member /p /li lipbF /bollowing customer SOPs and regulatory guidelines FDA, EU SwissMedic /p /li /ul pbJoin our Team! /b /p pWe are strongly committed to the development of your career and giving you opportunities to learn and grow. /p pWe make a difference for you while you make a difference in the world! /p /p #J-18808-Ljbffr