Senior Equipment Engineer

Job DescriptionWe are excited to announce a fantastic opportunity for a Senior Equipment Engineer at our state-of-the-art site in Dundalk.Our facility is dedicated to formulating and filling vaccine products that improve and transform lives globally.This role offers a unique opportunity to provide technical leadership and support for Vial Filling Equipment and associated machinery.By joining our team, you will play a crucial role in improving and transforming lives globally.Your Core ResponsibilitiesProvide technical leadership within a new Vaccine DP facility, ensuring equipment safety, effectiveness, and compliance.Adhere to company and site engineering policies and procedures, and review/authorship of testing protocols, reports, and manufacturing SOPs.Lead Commissioning & Qualification activities for new equipment and manage Equipment Vendors, including SAT, maintenance visits, and continuous improvement projects.Participate in cross-functional teams to troubleshoot technical issues, drive continuous improvement, and process optimization using DMAIC and FMEA tools.Manage changes to equipment/process as per site change control procedures and support the establishment of a Preventative Maintenance Program.You will have the opportunity to lead/participate in equipment-related manufacturing investigations to ensure root cause analysis, impact analysis, and CAPAs implementation.Provide technical expertise during regulatory inspections and support the transition from project to sustaining manufacturing, improving equipment reliability.Collaborate with the IPT Leader and multiple partners to ensure effective strategies, direction, and excellence in IPT/maintenance programs.Provide technical expertise during regulatory inspections e.g. FDA, HPRA inspections to defend systems, change controls, investigations and qualification packagesWho You AreYou are ready if you haveTechnical expertise in machine and equipment maintenance programs within a regulated cGMP environment.Proven ability to lead Commissioning & Qualification activities and manage Equipment Vendors and continuous improvement projects.Strong understanding of cGMP activities including RA and CQV protocols/reports.Ability to troubleshoot and resolve technical issues using DMAIC and FMEA tools.Experience in managing changes to equipment/process as per site change control procedures and leading/participating in equipment-related manufacturing investigations.Experience in regulatory inspections (e.g., FDA, HPRA inspections).Nice to have, but not essentialExperience in the pharmaceutical or biopharmaceutical industry.Knowledge of Preventative Maintenance Programs for equipment in Drug Product suites.Lean or Six Sigma experience.Current Employees apply HERECurrent Contingent Workers apply HERESecondary Language(s) Job DescriptionAs a company, we are committed to 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.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.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.Please feel free to speak to us about what flexibility means to you during your application.So, if you are ready toInvent solutions to meet unmet healthcare needs,please apply today.Search Firm Representatives Please Read CarefullyMerck & 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 StatusRegularRelocationVISA SponsorshipTravel RequirementsFlexible Work ArrangementsNot ApplicableShiftValid Driving LicenseHazardous Material(s)Required SkillsAdaptability, Analytical Problem Solving, cGMP Regulations, Change Control Procedures, Commissioning, Decision Making, FDA Regulations, Manufacturing, Manufacturing Operations, Preventive Maintenance, Process Improvements, Safety StandardsPreferred SkillsLean Six Sigma (LSS), Pharmaceutical Product DevelopmentJob Posting End Date09/20/2025A job posting is effective until PM 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.Requisition IDR