The role:
PE Global is currently recruiting for a Technical Transfer Engineer MS&T on behalf of a leading pharmaceutical company based in Dundalk. This is an initial 11 month contract role.
Overview:
The MS&T – Drug Substance Technical Operations (DS Tech Ops) organization 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 optimization.
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 standardized 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.
Education and Experience:
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
Desirable:
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.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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