Job DescriptionA new position has opened in our growing Technical Operations team at our Biotech facility in Swords, Dublin for an experienced Downstream Technical Operations Specialist.Why you should apply!Our state-of-the-art facility delivers lifesaving medication to patients all over the world at speed and scale. The site offers over 400 colleagues the chance to work in a pivotal hub of biologics-based medicines.This role provides exciting and interesting opportunities to work on multiple projects, ranging from manufacturing support activities to new product introductions and technology transfers to regulatory submissions. The role will deliver a diverse range of technical expertise and support to the Business. Work with the Integrated Process Team (IPT)to ensure the effective and efficient on-time delivery of batch production within the IPT area.Provide support for improvements to automation changes, including code and software as required and generate change controls to support execution.Lead, assist in and facilitate investigations, ensuring effect Root Cause Analysis and CAPA’s, data analysis and interpretation to resolve complex downstream operations deviations. Lead process improvement and troubleshooting with end-to-end product focus. Tactical Implementation & Support for reliability equipment initiatives. Provide technical, process and engineering expertise within a wide range of projects, such as the introduction of new equipment and processes. Perform Protocol/report authoring/execution/oversight/approval as appropriate. Author/approve Change controls and GMP documents as appropriate.Support Generation of SOPS/Electronic Batch Records and facilitate review workshops as deemed necessary. What skills you will need: To excel in this role, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams. You will have experience in: Change control generation and management.Proficiency in MES change management and UAT execution.Delta V updates for DS, change control generation, development system testing and any associated wet testing execution.Experience with Downstream bioprocessing and troubleshooting. Strong verbal and written communication skills, project management skills.At our company, we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. We are always looking to make a difference for people, patients, and communities – from Ireland to the world.Our Commitment to Ireland:Our Company Ireland is one of the Ireland’s leading healthcare companies, having first established here over 50 years ago. We have a dynamic and diverse team of over 3,000 employees currently working across seven sites in Ballydine, Co Tipperary, Brinny, Co Cork, Dunboyne, Co Meath, Carlow, and Dublin, where, in addition, operate substantial Human Health and Animal Health businesses. Through our long-standing footprint in Ireland and over $6 billion invested across our Irish operations, our Irish sites manufacture many of the company’s top products, helping save and enhance lives in over 140 countries around the world.As a company, we are committed to ‘Inventing for Life’ in all that we do. 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. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.So, if you are ready to:Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.Current Employees apply HERECurrent Contingent Workers apply HERESearch Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & 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. Employee Status: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:03/20/2025*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.