Job Description PSC Biotech is Hiring in Dundalk for One of Our Clients Our Engineers play a critical role in ensuring that both internal and external manufacturing operations run smoothly, drive continuous improvement, and foster innovation.
With access to a wide variety of facilities and environments, our Engineers can work across 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 Substance Technical Operations (DS Tech Ops) team is seeking a highly motivated individual for a Technology Transfer role.
DS Tech Ops is responsible for technology transfers and the commercial production of biological Drug Substances at our Dundalk site.
In this role, you will have the opportunity to engage in all aspects of Tech Ops, including supporting technology transfer execution, providing manufacturing process support to resolve commercial production challenges, and assisting with process and capacity optimization initiatives.
Responsibilities include: · 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.
Requirements Required Education, 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 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.
Requirements Required Education, 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 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.