Validation & Compliance Engineer

The OneSource team from PerkinElmer is looking for a Validation & Compliance Engineer to strengthen our team in Schachen, Switzerland. In this role, you will review and approve documentation for calibration, maintenance, and repair activities, release equipment for use, and manage changes, deviations, and CAPAs — in close cooperation with Calibration & Maintenance Engineers to ensure continuous GxP compliance. Document review & approval / Release of equipment Reviews and approves documents within the scope of calibration, maintenance, and repair work Works closely with internal and external Calibration & Maintenance Engineers to close any GDP gaps in the provided documentation Releases equipment after successful completion of calibration, maintenance, and repair work Processes Changes, Temporary Changes, Deviations, and CAPAs related to calibration and maintenance Participates as a member of cross-functional teams in Changes and investigations Data management / Administrative release Creates, updates, reviews, and releases items in the customers' calibration/maintenance databases (CCMS/CMMS) Reviews, approves, and performs the administrative release of successful calibration and maintenance entries in the customers' CCMS/CMMS systems Requirements Bachelor's degree in Life Sciences or a field related to Quality/Compliance or equivalent experience desirable At least five (5) years of relevant experience in a (bio-)pharmaceutical company in the areas of Quality, Validation, or Compliance Knowledge of cGMP, Annex 1 as well as validation regulations and requirements Knowledge of GMP, GLP, GDP, pharmacopoeia, and regulatory requirements is an advantage Strong customer orientation Passion for attention to detail and technical aspects Strong written and oral communication skills Ability to work both independently and in a team within prescribed guidelines while dealing with frequent gray areas/uncertainties