Senior BioProcess Associate – Upstream

<p style="text-align:left">Job Description</p><p style="text-align:inherit"></p><p>An amazing opportunity has arisen for a <b>Senior BioProcess Associate – Upstream </b>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>What you will do: </b></p><p>Bring energy, knowledge, innovation and leadership to carry out the following:</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><p></p><ul><li>2&#43; 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></ul><p></p><ul><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></ul><p></p><ul><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&#39;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&#39;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-based colleagues around the world.</p><p>Please feel free to speak to us about what flexibility means to you during your application.</p><p></p><p>So, if you are ready to:</p><p>Invent solutions to meet unmet healthcare needs, <b>please apply today.</b></p><p></p><p><b>Required Skills: </b></p>Aseptic Operations, Cleanroom Gowning, GMP Documentation, Mammalian Cell Culture, Master Batch Records, Pharmaceutical Manufacturing, Process Management, Production Scheduling, Standard Operating Procedure (SOP) Writing<p></p><p><b>Preferred Skills: </b></p><p style="text-align:inherit"></p><p style="text-align:left">Current Employees apply <a target="_blank" href="https://wd5.myworkday.com/msd/d/task/1422$6687.htmld">HERE</a></p><p style="text-align:inherit"></p><p style="text-align:left">Current Contingent Workers apply <a target="_blank" href="https://wd5.myworkday.com/msd/d/task/1422$4020.htmld">HERE</a></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Search Firm Representatives Please Read Carefully </b><br />Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. </p><p style="text-align:inherit"></p><p style="text-align:left"><b>Employee Status: </b></p>Regular<p style="text-align:inherit"></p><p style="text-align:left"><b>Relocation:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>VISA Sponsorship:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b><span>Travel Requirements:</span></b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Flexible Work Arrangements:</b></p>Not Applicable<p style="text-align:inherit"></p><p style="text-align:left"><b>Shift:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Valid Driving License:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Hazardous Material(s):</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Job Posting End Date:</b></p>03/17/2026<p style="text-align:left"><b><span>*A job posting is effective until 11:59:59PM on the day <u>BEFORE</u> the listed job posting end date. Please ensure you apply to a job posting no later than the day <u>BEFORE</u> the job posting end date. </span></b></p>