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 Utilities
* Computerized Systems and Automation Packages
Responsibilities:
* Prepare, review and approve documentation forcGMP / 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 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 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.
* Strong attention to detail and accuracy.
* Strong interpersonal skills to support relationships with a number of stakeholders.
* Project planning experience a distinct advantage
Technical/Functional Expertise
* Must have experience in validation disciplines such as:
* Process and Packaging Equipment (OSD)
* Facilities and Utilities
* Computerized Systems and Automation Packages
* Manufacturing and Packaging Processes
* Cleaning Validation
* Excellent 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 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
Qualifications:
* 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
* Risk focused