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.Overview:We are looking for a BioProcess Associate – to join our Drug Substance team at our state-of-the-art, fully integrated vaccine facility in Ireland. As a Bioprocessing Associate, you will be a key member in our fast-growing, dynamic startup-working with cutting-edge technology.RequirementsResponsibilities:Manufacturing processes include DS Downstream Processing (DSP) and Upstream Processing (USP) and Buffer / Media preparationCarry out all production operations in the assigned area as per the relevant SOPs and Manufacturing Batch Records .Assist in maintaining a safety orientated Culture, cGMP compliant work environment at all timesWrite, review and revision of area Standard Operating Procedures (SOPs), On the Job Training (OJT's), Production Batch Records (PBRs), Logbooks, Training Competencies and Work InstructionsTraining and mentoring of colleagues in SOPs, process execution and equipment operation.Support Manufacturing team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Safety, Quality, Schedule adherence, Overall Equipment Effectiveness (OEE), and team training.Assist with the investigation of and operations deviations through Quality System, engaging with all relevant personnel and functions as appropriate.Lead and actively participate in shift handovers.Liaise with Shift Lead regarding issues which may arise within the production area including highlighting of operational challenges.Use Lean Tools as part of daily operations (Standard Work, 5S, TPM, Gemba, Method 1,) to optimize efficiency and drive the culture of Continuous Improvement (CI)Support HAZOP and risk assessments as per requirements.Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.Conducts all activities that are in accordance with Company policies & SOPs & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate.Support the development, commissioning & qualification of a new vaccines drug substance manufacturing equipment and subsequent transition to commercial manufacturing.What skills you will need:Demonstrated experience in Bioprocessing, Upstream or Downstream.Knowledge and experience of relevant cGMP, safety, and environmental regulations within the biopharmaceutical industry.High level of adaptability working in a fast-paced environment and champion change.Experience with recording information in real time using electronic or manual systems.Experience in executing operations while following SOPs, Batch Records and Manufacturing Controls Systems.Experience of working in Grade C, D and CNC environment is an advantage.Excellent interpersonal skills, positive influence, team orientation, attention to detail, documentation skills, problem identification and problem-solving skills.An ability to work independently, and as a member of a self - managed shift team in a dynamic, fast-paced environment that requires flexibility and initiative.Shift Pattern:This position will initially operate standard office hours Monday-Friday but will be transition in Extended 7-day shift pattern with 12-hour shifts, designed to provide 24/7 coverage using a 4-week repeating cycle. Two teams rotate through this scheduleExample :Week 1: Work Monday, Tuesday, Friday, Saturday, Sunday (12-hour day shifts),Off Wednesday and ThursdayWeek 2: Work Wednesday and Thursday only, Off the other 5 daysWeek 3: Same as Week 1: Work Monday, Tuesday, Friday, Saturday, SundayWeek 4 Same as Week 2 :Work Wednesday and Thursday only