Technology Transfer Specialist/Engineer (Drug Product)
Location:
Dundalk, Ireland
Type of contract
: contract of employment, fixed term
Length of contract
: 12 months with possible extension
Pay rate
: EUR/ hour
Ltd contract
Work model
: onsite
Client:
A premier research-intensive biopharmaceutical company, committed to being at the forefront of research, delivering innovative health solutions that advance the prevention and treatment of diseases in both people and animals.
Our Engineers help ensure that internal and external manufacturing operations remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.
The Manufacturing Science and Technology (MS&T) – Drug Product Technical Operations (DS Tech Ops) organization is seeking a highly motivated individual for a Technology Transfer position. DP Tech Ops is accountable for technology transfers and commercial production of finished Drug Product 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 include:
* Work with Internal Partners to achieve business goals.
* Provide support within the Drug Product manufacturing team including areas such as Formulation, Filling, Lyophilisation, Capping and Automated Visual Inspection.
* Responsible for process ownership, demonstrating technical excellence as the subject matter expert (SME) for drug product processes
* 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 technology 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 Commercial and / or 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 and Quality
* Ensure that Site is 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 Minimum Requirement:
* Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
Required Experience and Skills:
* 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
* Strong communication in English and teamwork skills
Preferred Experience and Skills:
* Proven expertise in aseptic operations, analytical testing, process development and tech transfer.
* Knowledge of USP1790 and industry/ regulatory requirements such as Annex 1 desirable
* Experience with lyophilized products advantageous
* Experience in start-up facility advantageous
* 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 equipment qualification, and/or project management.