Commissioning And Qualification (C&Q) Execution Specialist

Summary Commissioning and Qualification (C&Q) Execution Specialist, you will be responsible for managing and executing the commissioning and qualification activities within the biopharmaceutical industry. Your role will involve ensuring that manufacturing equipment, facilities, utilities, and systems are properly installed, tested, and validated according to regulatory requirements and industry standards. All Validation execution activities will perform in the KNEAT paperless validation system.Job Location: Onsite, Laval QuebecMain Accountabilities:Support the C&Q Execution Project Manager towards delivering the complete IV Execution project scope of work, on time and within budget.�Issuance of Site CQV equipment qualification and validation documentation (in general, ETOPs, IOQ, PQ, and associated Summary Reports) related to FUSE (Facility, Utility, System, Equipment) systems for Drug Substance Operations at the Laval Site�Execution of Site CQV protocols (IOPQs) per systems master list in scope and Site CQV Plan which may include various types of execution protocols such as �P&ID and slope verification �Critical Component and Calibration Verification�Hygienic Pipework and Passivation Documentation Verification�URS Safety, Design, and Construction Item Verification�Startup and Shakedown verification �Loop and dead leg verification �Perform Environmental Monitoring Performance Qualification (EMPQ) to validate the performance of the Facility/HVAC system�Create Qualification Summary Report (QSR) to summarize the results of FUSE elements systems�Issuance and management of any discrepancies and deviations�Assist technical stakeholders in support of CQV activities and Project Implementation (Quality, Process Engineering, Project Managers, MSAT, Engineering)�Proactively notify the C&Q Project Manager of any potential delays or impacts to the quality and delivery of work package documents to enable quick risk mitigation and avoid schedule impacts.�Plan, schedule, and track progress and milestones using appropriate tools to provide that information to the C&Q Project Manager, as requiredMinimum Education Requirements1.Bachelor�s degree in Engineering or Science (a degree in Mechanical or Electrical Engineering would be preferred).2.Good to have KENAT end-user experience or certification3. Efficient in French language will be preferredMinimum Experience Requirements1.4+ years of commissioning & qualification experience working in bio/pharmaceutical manufacturing environments.2.Familiarity with applicable Canada, US FDA, and WHO regulatory requirements.3.Demonstrate a high degree of meticulousness and proactivity.4.Excellent reading and writing skills in the English language.5.Excellent technical and communication skills."