Role Title: Bioprocess AssociateRole Type: 12 month contractLocation: DundalkWe are looking for a BioProcess Associate – to join a Drug Substance team at a state‑of‑the‑art, fully integrated vaccine facility in Dundalk, Ireland. As a Bioprocessing Associate, you will be a key member in a fast‑growing, dynamic startup working with cutting‑edge technology.Please note this position will initially operate standard office hours Monday‑Friday but will transition to a 12 hour day shift pattern or 4‑cycle shift pattern to support routine site operations.ResponsibilitiesManufacturing processes include DSP (Downstream Processing) and USP (Upstream Processing) and Buffer/Media preparationCarry out all production operations in the assigned area as per the relevant SOPs and Manufacturing Batch RecordsAssist in maintaining a safety‑oriented culture, cGMP compliant work environment at all timesWrite, review and revise area Standard Operating Procedures (SOPs), On‑Job Training (OJT’s), Production Batch Records (PBRs), Logbooks, Training Competencies and Work InstructionsTraining and mentoring of colleagues in SOPs, process execution and equipment operationSupport Manufacturing team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Safety, Quality, Schedule adherence, Overall Equipment Effectiveness (OEE), and team trainingAssist with the investigation of and operations deviations through Quality System, engaging with all relevant personnel and functions as appropriateLead and actively participate in shift handoversLiaise with Shift Lead regarding issues which may arise within the production area including highlighting of operational challengesUse 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 requiredProvide assistance and/or support maintenance, engineering, quality or other colleagues as requestedConduct all activities that are in accordance with company policies & SOPs & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriateSupport the development, commissioning & qualification of new vaccine drug substance manufacturing equipment and subsequent transition to commercial manufacturingWhat Skills You Will NeedIn order to excel in this role, you will more than likely have:Demonstrated experience in Bioprocessing, Upstream or DownstreamKnowledge and experience of relevant cGMP, safety, and environmental regulations within the biopharmaceutical industryHigh level of adaptability working in a fast‑paced environment and champion changeExperience with recording information in real time using electronic or manual systems??Experience in executing operations while following SOPs, Batch Records and Manufacturing Controls SystemsExperience 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
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