CQV Engineer (Projects)There is a requirement to hire a CQV Engineer to join the Bray Site Engineering Services Department to support the current and future pipeline of CAPEX Projects including but not limited to:Process and Packaging Equipment (OSD)Facilities and UtilitiesComputerized Systems and Automation PackagesResponsibilities:Prepare, review and approve documentation forcGMP / Validation of the following:Equipment, Facility, UtilityComputerized Systems and Automation PackagesManufacturing and Packaging ProcessesProvide input into project phases from design, commissioning and qualification.Preparation, review and approval of Comissioning and Validation documentation.Document, resolve and assist in the closure of commissioning punch lists and validation deviations initiated during commissioning and qualification activities.Initiate and management of change control records.Evaluate quality standard of service providers for cGMP, including Validation requirements (Vendor qualification documentation).Vendor management during commissioning and qualification activitiesCompile, review and approve cGMP documentationEnsure up-to-date regulatory requirements for all validated operationsWork with management and staff to foster an ethos and culture of cGMP & Quality awareness, where the cGMP's and Quality are an integral part of the overall business.Ensure site wide compliance to the cGMP's including data integrity.Management of Validation schedules and timelines.Strong attention to detail and accuracy.Strong interpersonal skills to support relationships with a number of stakeholders.Project planning experience a distinct advantageTechnical/Functional ExpertiseMust have experience in validation disciplines such as:Process and Packaging Equipment (OSD)Facilities and UtilitiesComputerized Systems and Automation PackagesManufacturing and Packaging ProcessesCleaning ValidationExcellent technical writing and verbal communication skills.Strong tehnical writing ability a must (GMP Change Controls, GMPA Risk Assessment, drafting of VMP's, URS's, DQ's, FATs, IOQ's, IOQR's, GMPA's etc)Specific projects to be executed are generally in the Processing and Packaging areas of theTakeda Bray site and include:Upgrade to high speed Capsule Filling equipment to accommodate granule handlingNew product introductions (NPI) in the drug product environmentUpgrades to process equipment utilities & associated plantUpgrades to high speed Blisterline equipment (Uhlmann)New product introductions in the packaging environment, format partsGeneral asset care equipment upgrades in all areas of packagingQualifications:Bachelor's degree preferably in Engineering, Science or other technical field (engineering degree preferred).Minimum of 5 years related experience in pharmaceutical manufacturing environment, validation, operations, engineering, or any combination thereof.Experience in Production and or Packaging processes and control systems, process equipment, facilities and utilities.Experience in technical writing of GMP related documentationExperience in risk assessments drafting and risk based approach test protocol creation in relation to validation activities.Experience of Electronic Documentation Management Systems (KNEAT, VEEVA, TRACKWISE)Strong attention to detail and accuracy.Strong interpersonal skills to support relationships with a number of stakeholdersPast experience writing, reviewing and executing validation documentation (Validation Plan, FAT, SAT, IQ, OQ, PQ, RTM, summary report) an advantageExperience in a large company environmentHigh leadership skillsetHigh strategic thinkingHigh facilitation and presentation skillsetCapability of analyzing and solving complex problems through innovative thought and experienceTeam based playerQuality and EHS awarenessRisk focused