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:
1. 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
2. Must have 2 -3 years biological
drug substance experience for this role
3. Strong communication and
teamwork skills
Preferred Experience and Skills:
4. Demonstrated ability to
independently manage projects/work to schedule/deadlines
5. 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.