Validation & Compliance Engineer

Job description

When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services. Job Title Validation & Compliance Engineer Location(s) MSD (Switzerland) - Customer Site Job Description PerkinElmer's OneSource team is looking for a Validation & Compliance Engineer to join the team 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 Responsibilities: Document Review & Approval / Asset Release Reviews and approves documents as part of calibration, maintenance, and repair work Collaborate closely with internal and external Calibration & Maintenance Engineers, to close eventual GDocP gaps in provided documentation Releases assets after successful completion of calibration, maintenance, and repair work Processes Changes, deviations, and CAPA related with calibration and maintenance Contributes to changes and investigations as a member of cross-functional teams Data Management / Administrative Release Adds, updates, reviews, and releases asset records in the customer calibration/maintenance databases (CCMS/CMMS) Reviews, approves, and performs administrative release of successful calibration and maintenance entries in Customer CCMS/CMMS systems Requirements 3 to 5 years of relevant experience in a (Bio-)Pharma company in quality, validation or compliance roles Expert in CCMS/CMMS Operator process specialist experience Bachelor’s degree in a Life Sciences or Quality/Compliance discipline or equivalent experience preferred. Knowledge of cGMP and validation regulations and requirements Knowledge of GMP, GLP, GDocP, pharmacopeia and regulatory requirements preferred. Developed Customer service mindset Be passionate in attention to detail and tech aspects Strong written and verbal communication skills in English, German language knowledge will be beneficial. Ability to work both independently and as a team member, adapt to changing environment Following customer SOPs and regulatory guidelines FDA, EU & SwissMedic Join our Team! We 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!