Job InformationDate Opened11/03/2025Job TypeContractIndustryPharma/Biotech/Clinical ResearchWork Experience4-5 yearsCityCarlowState/ProvinceCarlowCountryIrelandJob DescriptionAbout 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.Overview:Provide process engineering services in support of upgrade projects in an existing Sterile Filling Facility. The job-holder works with the Process Engineering Team and act as the Package Owner and Vendor Point of Contact for new process equipment and upgrades to existing process equipment.The Senior Process Engineer will work within cross functional teams to deliver a significant suite or multiple suites of related process scope.RequirementsResponsibilities:Act as Package owner for new process equipment and upgrades to existing process equipment.Manage vendor(s) for critical equipment detailed design, fabrication, installation on site and delivery up to PQ completion.Develop Process Flow Diagrams, P&IDs, User Requirement Specifications and Equipment Specifications to ensure Process Descriptions/Needs are met.Facilitate team to complete process safety deliverables including PHA (Hazops).Ensure Global engineering standards, procedures and practices are followed in the design development.Work as part of a cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.Ensure all project stakeholders are consulted on key process suite activities.Monitor progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders.Support GES C&Q Lead to coordinate preparation and C&Q field execution.Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation, and C&Q documentation.Manage installation / start-up / testing of process systems through OQ completion. Interface with cross-functional team to ensure systems' post-OQ (PQ, PPQ) readiness.Liaise with stakeholders, equipment vendors, business partners, and SMEs at other sites within the Manufacturing Network as required to support Project.The job-holder may also undertake Project Engineering duties including preparation of project related deliverables such as schedules, work plans, or equipment cost tracking.Education/Experience Requirements:Minimum qualification B.Sc. or M.Sc./ M.Eng Degree in Chemical or Biochemical Engineering or equivalent discipline.Minimum of 5 years post academic process engineering experience. Aseptic/sterile processing design, construction & start-up experience would be preferred.Demonstrated ability to lead / influence teams in matrix environmentExcellent communication/presentation/organizational skillsIn depth understanding of process engineering and technologies pertinent to formulation and filling unit operations.Knowledge of SDLC methodologyThis is a contract position. Requested start is January 2026 with initial 11 month contract