About PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.'Take your Career to a new Level'PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.Employee Value PropositionEmployees are the "heartbeat" of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client's expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.PSC Biotech is Hiring in Dundalk for One of Our ClientsOur 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.TheManufacturing Science and Technology (MS&T) – Drug Substance Technical Operations (DS Tech Ops)team is seeking a highly motivated individual for aTechnology Transferrole. 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.TheManufacturing Science and Technology (MS&T) – Drug Substance Technical Operations (DS Tech Ops)team is seeking a highly motivated individual for aTechnology Transferrole. 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.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 MaintenanceMust have 2-3 years biological drug substance experience for this roleStrong communication and teamwork skillsPreferred Experience and Skills:Demonstrated ability to independently manage projects/work to schedule/deadlinesStatistics 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.