Senior Specialist, Manufacturing Automation
PharmaBiotechMedTechRegulatory AffairsQuality Assuranceemafdahpracrorave
Job description
Job Description An exciting opportunity has arisen for an experienced Senior Automation Engineer to join our Digital Manufacturing Operations (DMO) team at our Biotech Dublin facility. In this role, you will support the reliable, compliant and efficient operation of critical automation systems used to manufacture biologics, while also contributing to continuous improvement and launch excellence projects that enhance our manufacturing performance and production capabilities. Working under the guidance of the DMO Area Lead you will provide senior-level automation support across DeltaV, OEM and digital manufacturing systems, combining hands-on troubleshooting with technical leadership, team mentoring, change control ownership, continuous improvement and project delivery. Bring energy, knowledge, innovation to carry out the following: Provide senior automation support for manufacturing systems including DeltaV DCS, OEM systems, data historians and associated digital platforms Support the site Launch Excellence strategy, supporting the planning, implementation, and launch of new products at Biotech Dublin Troubleshoot complex automation and process control issues to support reliable manufacturing operations, deviation resolution and right-first-time performance Lead and support automation changes from scoping through implementation and closure, ensuring delivery to schedule and in line with site quality standards Review equipment specifications, P&IDs, control strategies and system lifecycle documentation to ensure robust and compliant automation design Support site commissioning, qualification, validation and test execution activities for new and modified automation systems Collaborate with Manufacturing operations, Quality, Validation, Engineering, IT and Digital teams to deliver compliant, value-focused automation solutions Contribute to digital transformation initiatives involving system integration, data connectivity, manufacturing intelligence and process optimisation Act as a technical role model within a high-performing team, sharing knowledge and supporting a culture of safety, compliance, inclusion and continuous improvement What skills you will need: In order to excel in this role, you will more than likely have: Education: Bachelor’s degree in Engineering, Automation, Computer Science or a related technical discipline (or equivalent practical industry experience) Experience: 5+ years of progressive automation or process control experience in a regulated GxP environment (biopharmaceuticals, pharmaceuticals or medical devices) Core Systems: Proven technical proficiency with distributed control systems (Emerson DeltaV DCS) and industrial PLC/HMI/SCADA platforms (e.g., Siemens) Historians: Practical working experience with manufacturing data historians (e.g., OSIsoft PI) Validation & Standards: Demonstrated experience delivering automation projects in alignment with SDLC / GAMP 5 methodologies, alongside a solid working knowledge of ISA-88 and ISA-95 principles Collaboration & Communication: Strong interpersonal and communication skills, with a proven ability to influence, collaborate, and explain complex technical concepts across cross-functional teams Preferred qualifications: Direct experience with shop-floor digital integrations (e.g., MES, ERP interfaces, IoT smart sensors Familiarity with industrial network architectures, server virtualization, and cybersecurity fundamentals Prior experience supporting regulatory agency audits or health authority inspections (e.g., HPRA, FDA) Experience conducting business value or continuous improvement analysis (e.g., Lean Six Sigma, MPS) 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. 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 to: Invent solutions to meet unmet healthcare needs, please apply today . Required Skills: Change Controls, Corrective and Preventive Action (CAPA), Deviation Investigations, Emerson DeltaV, Historian (Software), Launch Readiness, Leadership, Mentorship, New Product Introduction (NPI) 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: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 10/8/2026 *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.
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