Senior BioProcess Associate

<p>Job Description</p><p></p><p>We are looking for a Senior BioProcess Associate – (DS Upstream) to join our Drug Substance team at our state-of-the-art, fully integrated vaccine facility in Dundalk Ireland. As a Senior Bioprocessing Associate, you will be a key member in our fast-growing, dynamic startup-working with cutting-edge technology.</p><p></p><p>Please note This position will initially operate standard office hours Monday-Friday but will transition to a 12hr day shift pattern or 4 Cycle shift pattern to support routine site operations.</p><p></p><p><b>Bring energy, knowledge, innovation to carry out the following:</b></p><ul><li>Manufacturing SME in the following areas: WCB, WVS, Media formulation, Vail thaw, Cell Expansion, Bioreactor, Harvest.</li><li>Work with the manufacturing team in executing those tasks in a safe, compliant, and efficient manner to maintain production schedules.</li><li>Carry out all production operations in the assigned area as per the relevant SOPs and Manufacturing Batch Records (paper and electronic).</li><li>Write, review and revision of area Standard Operating Procedures (SOPs), On the Job Training (OJT’s), Production Batch Records (PBRs), Logbooks, Training Competencies and Work Instructions.</li><li>Assist where necessary with the training of colleagues in SOPs, process execution and equipment operation.</li><li>Support the development of training matrices and ensuring compliance to training requirements.</li><li>Assist with the investigation of and operations deviations through Quality System, engaging with all relevant personnel and functions as appropriate.</li><li>Lead and actively participate in shift handovers.</li><li>Liaise with Shift Lead regarding issues which may arise within the production area including highlighting of operational challenges.</li><li>Perform initial troubleshooting of issues identified during routine operations.</li><li>Assist in driving and maintaining a safety orientated Culture, cGMP/GDP compliant work environment at all times.</li><li>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).</li><li>Support HAZOP and risk assessments as per requirements.</li><li>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.</li><li>Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.</li><li>Conducts all activities that are in accordance with Company policies &amp; SOPs &amp; global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate.</li></ul><p></p><p><b>What skills you will need:</b></p><p>In order to excel in this role, you will more than likely have:</p><ul><li>2+ years experience in biopharmaceutical manufacturing with experience in upstream processing.</li><li>Experience in operating a drug substance pilot plant and/or a commercial facility.</li><li>Strong background in cellular metabolism, various mammalian cell lines, and be scientifically minded.</li><li>Hands-on experience with various size bioreactors (SUB) and applying the previously mentioned techniques across those scales is desired.</li><li>Expertise and specific experience in Vero Cell Expansion in CCS is preferred.</li><li>Equipment experiences in Single use bioreactor, ViCell, NuceoCounter, Nova, Microscope, Integrity tester, BSC, Tubing Pump, Tubing Welder &amp; Sealer, Magnetic stirrer, CO2 Incubator.</li><li>Ability to positively influence and work well with others.</li><li>Ability to troubleshoot with tools such as 5 whys &amp; Fishbone, DMAIC.</li><li>Comfortable making risk-based decisions.</li><li>Knowledge and experience of relevant cGMP, safety, and environmental regulations within the biopharmaceutical industry.</li><li>Previous experience acting as designee to the shift lead role is advantageous.</li><li>Experience in coordinating shift activities and escalation of issues to ensure all manufacturing processes are complied with is advantageous. Self-motivated with excellent communication and interpersonal skills.</li><li>High level of adaptability working in a fast-paced environment and champion change.</li></ul><p></p><p>We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.</p><p></p><p>As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.</p><p></p><p>We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-bas