Responsibilities:Execution of the following activities for the relevant systems in accordance with Project procedures/guidelines:System Boundary development and approvalDesign Qualification preparation, execution and approval. Includes release for IQGMP-RA’sCommissioning preparation, execution and approval. Includes vendor supervision on their testing scope and qualityInstallation Qualification preparation, execution and approval. Includes release for OQOperational Qualification preparation, execution and approval. Includes release to OPSProvide support in execution of Design Qualification for other direct impact systemsProvide support in the implementation of the Installation Commissioning process in accordance with Project procedures/guidelinesShall be able to work/support another C&Q activity if deemed necessaryMinimum Requirements:Minimum Bachelor’s degree in Life Sciences or EngineeringSolid experience in commissioning/qualification/validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech industryProven experience on performing qualification (IQ and OQ) on CIP skidsSolid experience in commissioning/qualification/validation of Clean Utilities SystemsExperience with DeltaV (Emerson)Fluent English language written and verbal communication skillsCGMP knowledge and knowledge of regulatory requirementsAble to work with minimum oversight fulfilling deliverables within target datesPreferred requirements: experience with Lonza Commissioning/Qualification Approach and COMOS/KNEAT PlatformsExperience with COMOS/KNEAT platformsAdditional Information:Further training opportunitiesFriendly working environment
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