Our client is a pharmaceutical company based in South Dublin looking for a CQV Engineer to support the current and future pipeline of CAPEX Projects including but not limited to Process and Packaging Equipment (OSD), Facilities and Utilities and Computerized Systems and Automation Packages.
Responsibilities:
• Prepare, review and approve documentation for cGMP / Validation of Equipment, Facility, Utility, Computerized Systems and Automation Packages and Manufacturing and Packaging Processes
• Provide input into project phases from design, commissioning and qualification.
• Preparation, review and approval of Commissioning 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 activities
• Compile, review and approve cGMP documentation
• Ensure up-to-date regulatory requirements for all validated operations
• Work 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 cGMP including data integrity.
• Management of Validation schedules and timelines.
Qualifications & Experience:
• 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 documentation
• Experience 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.
• Past experience writing, reviewing and executing validation documentation (Validation Plan, FAT, SAT, IQ, OQ, PQ, RTM, summary report) an advantage
• 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)
• Upgrade to high speed Capsule Filling equipment to accommodate granule handling
• New product introductions (NPI) in the drug product environment
• Upgrades to process equipment utilities & associated plant
• Upgrades to high speed Blisterline equipment (Uhlmann)
• New product introductions in the packaging environment, format parts
• General asset care equipment upgrades in all areas of packaging