Senior Manufacturing Operations Specialist

Job description

Job Description An amazing opportunity has arisen for a Senior Manufacturing Operations Specialist to join our Manufacturing Hub at our new, state-of-the-art, single-use multiproduct biotech facility in Dunboyne. What you will do: You will act as an individual contributor with a focus on specific downstream unit operations for the downstream IPT. You will develop, communicate, and execute a data-driven cross-enterprise schedule to ensure successful site delivery, achieving our Governance Pillars in People, Safety, Quality, Delivery, and Cost. This role is critical for managing the production schedule, planning changeovers, conducting audits, and optimizing plant operations to ensure effective and efficient production through driving a safety, compliance and right-first-time mindset. You will deliver key metrics alongside their designated team of Manufacturing Specialists and as an individual contributor for areas such as: Execution Excellence/Process Improvement Compliance Excellence Audit preparation Next generation digital and CI activities Problem Solving and Root Cause Analysis New Product Introductions Technical Support Trend Identification and Issue Resolution Purpose: This role is essential for establishing and advancing our new facility in Dunboyne. You will support all project milestones and commercialization activities with a "safety first, quality always" mindset. You will be a key driver of continuous improvement and standard work principles, ensuring adherence to all divisional policies and regulatory requirements. Key Responsibilities: Collaborate with the Integrated Process Team (IPT) and Operations to ensure the on-time delivery of batch production, consistently meeting Key Performance Indicators (KPIs) for EHS, production schedules, and compliance. Serve as a primary technical expert for all manufacturing processes and equipment, leading projects and maintaining a high personal level of working knowledge. Act as a key contact for introducing new process equipment to the facility, providing technical support and training to manufacturing personnel during implementation and handover. Drive continuous improvement initiatives by leading cross-functional teams to resolve complex issues, manage equipment changes, and implement process optimizations. Take ownership of specific Electronic Batch Records (EBRs), making technical changes as required by business needs or process updates, and support updates to the Process Automation System (PAS). Lead the generation and approval of essential GMP documentation, including change controls, significant technical investigations, and materials for regulatory filings and health authority inspections. Provide ongoing technical support to cross-functional team members, including maintenance, engineering, and quality, to resolve issues and share best practices. Ensure the consistent supply of high-quality product by proactively resolving issues, identifying risks, and guaranteeing equipment availability and readiness. Education & Experience: Minimum Level 7 qualification in Science, Engineering or related discipline. Proven record of accomplishments of working for a minimum of 5 years in a Pharma/Biopharma company or related industry is desirable. Proven ability around working cross functionally, focusing on meeting and tracking to schedules and embracing an interdependent work culture. Experience working in a GMP/regulated environment is required. 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. Required Skills: Adaptability, Analytical Problem Solving, Conflict Resolution, Continuous Process Improvement, Data Analysis, Decision Making, GMP Compliance, Lean Six Sigma Continuous Improvement, Manufacturing Technologies, Pharmaceutical Manufacturing, Problem Solving, Process Improvements, Process Manufacturing, Process Optimization, Production Scheduling, Risk Management Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search 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: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 08/29/2026*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.