CQV Engineer

Role Summary:

• Our client, based in Co. Wicklow, is looking for a CQV Engineer to join their team on their pharmaceutical site.
• The successful candidate will support the current and future pipeline of CAPEX Projects including but not limited to:
• Process and Packaging Equipment (OSD)
• Facilities and Utilities
• Computerized Systems and Automation Packages

Core Duties and Responsibilities:

• Prepare, review and approve documentation for cGMP / Validation of the following:
  • Equipment, Facility, Utility
  • Computerized Systems and Automation Packages
  • 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 the cGMP’s including data integrity.
• Management of Validation schedules and timelines.

Minimum Qualifications and 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.
• Strong interpersonal skills to support relationships with a number of stakeholders
• Past experience writing, reviewing and executing validation documentation (Validation Plan, FAT, SAT, IQ, OQ, PQ, RTM, summary report) an advantage
• Experience in a large company environment
• High leadership skillset
• High strategic thinking
• High facilitation and presentation skillset
• Capability of analyzing and solving complex problems through innovative thought and experience
• Team based player
• Quality and EHS awareness

Please note, we do not require agency assistance with this role.