Technology Transfer Engineer
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The Manufacturing Science and Technology (MS&T) - Drug Substance Technical Operations (DS Tech Ops) organisation is seeking a highly motivated individual for a Technology Transfer position. DS Tech Ops is accountable for technology transfers and commercial production of biological Drug Substance at our Dundalk site. This person will have the opportunity to participate in all areas of Tech Ops. This may include supporting the execution of technology transfers, providing manufacturing process support to resolve commercial production issues, and to provide support for process and capacity optimisation.
Responsibilities
* Work with Internal Partners to deliver technical transfer of our drug substance program
* Responsible for technical activities for the commercial manufacturing process, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
* Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
* Provide on-site coverage in support of Technology Transfer Person-In-Plant Activities.
* Translate understanding of GMP requirements and current regulations and develop standardised work to meet these requirements by partnering with Operations, Quality, and other Internal Partners.
* Ensure that External Partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory.
* Responsible for participation in creating, sharing, and adopting best practices and business process strategies.
Qualifications
* Minimum of 3 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance
* Must have 2-3 years biological drug substance experience for this role
* Strong communication and teamwork skills
Preferred Experience and Skills:
* Demonstrated ability to independently manage projects/work to schedule/deadlines
* Statistics experience (including Proactive Process Analysis and Continuous Process Verification)
* Experience in deviation management and/or change control and/or equipment support, and/or project management.