Job Description
Fill Finish Process Engineer (Pre-Filled Syringe SME)Industry: Pharma/Biotech/Clinical ResearchWork Experience: 5+ yearsCity: CorkState/Province: CorkCountry: IrelandJob DescriptionAbout PSC BiotechPSC 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 points 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 to 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 through Learning & Development, in-house training, mentorship, and constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client’s expectations regarding the quality of all scalable and business unit deliverables, staying under budget, and ensuring timelines for our deliverables are being met.Overview: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 External Manufacturing (ExM) Technical Operations organization is seeking a highly motivated individual for this support position. ExM Tech Ops is accountable for technology transfers and commercial production of sterile drug products at our External Partners (EPs). This person will have the opportunity to participate in all these areas, including supporting the execution of technology transfers, providing manufacturing process support to resolve commercial production issues, and providing support for process and capacity optimization.RequirementsResponsibilities include:Work with External Partners to achieve business goals and establish a common culture that benefits our company, External Partners, and patients.Responsible for technical activities for the commercial manufacturing process at the External Partner, 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 at External Partner 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, Quality, and External 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.Must have fill finish Pre-Filled Syringe experience for this role (Minimum 3-5 years).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 4 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.Travel will be a requirement of this position at approximately 25-50%.Strong communication and teamwork skills.Preferred Experience and Skills: Experience in Fill Finish activities (Vial/Syringe finish, sterilization, cleaning, aseptic manufacturing, etc.).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. #J-18808-Ljbffr