Maintenance Systems Engineer

Job Description

We are seeking an Engineering Specialistlevel Maintenance Systems Engineer with SME experience to support large GMP this role you will manage CMMS data and calibration management (ProCal or similar) maintain contract oversight and SLA management Engage and support both Local and Global Initiatives across EHS Quality Maintenance and Engineering within a Production environment. Uphold data integrity and validated documentation standards and contribute to reliability engineering initiatives. You excel at building relationships across Production Quality EHS and Engineering can delegate effectively within project teams and balance people and business needs across programmes and projects.

What you will do:

Bring energy knowledge innovation and leadership to carry out the following:

• Maintain and optimise the CMMS and CCMS configurations (asset hierarchy PM libraries workflows) and ensure clean reconciled reports manage procurement requests inventory and budget spend tracking.
• Master data accuracy (FLOCS/assets BOMs spareparts vendor records PMs) ensuring maintenance and financial records are auditable and ALCOA compliant.
• Translate priorities into effective short and longterm schedules allocate technician shifts and skills balance workload across teams and maintain activitylevel loading to optimise RFT minimise downtime and protect OTIF.
• Create and maintain workorder & calibration impact matrices; develop CMMS workflows to prevent closeout without required attachments and approvals.
• Reconcile maintenance costs between Expense and budget reconcile monthly MRO and expense spend support budget reporting conduct variance analysis and provide data for business cases and ROI calculations for maintenance investments and costreduction initiatives.
• Maintain precompiled audit packs/reports and ensure maintenance evidence (work histories calibration certs change controls CAPAs) is readily retrievable support inspections as the systems SME and address auditor queries regarding system controls and data integrity.
• Produce and maintain rolebased dashboards and reports covering maintenance performance (CMMS RFT schedule adherence) workorder status PM compliance and financial indicators (cost per work order cost vs budget).
• Develop and deliver training for maintenance staff and contractors on CMMS/CCMS use documentation expectations dataintegrity principles and scheduling practices; maintain a BKM repository and support crosssite knowledge exchange.
• Participate in change control pertaining to all maintenance systems and data quality. Manage process / equipment improvements through completion of projects as required.
• Act as a liaison between Maintenance Quality/Validation Procurement Finance and IT to ensure systems processes and data meet operational regulatory and financial requirements.
• Drive continuous improvement identify need for new equipment and/or modifications to existing equipment to optimize throughput and reduce process cycle times.
• Troubleshoot equipment problems perform root cause analysis on system failures and substandard equipment performance using standard tools and methods to resolve machine and system issues e.g. FMEA Fishbone diagrams 5 whys etc.
• Drive and participate effectively in writing/revising/rolling out accurate operational procedures training materials and maintenance procedures for various IPT systems.
• Leadership activities including selection development coaching and day to day management.
• Required to comply with Global Policies Procedures and Guidelines regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
• Work collaboratively to drive a safe and compliant culture in Carlow.
• May be required to perform other duties as assigned.

What skills you will need:

In order to excel in this role you will more than likely have:

Minimum

• Bachelors degree in Manufacturing/Mechanical/Electrical/Instrumentation Engineering.
• Minimum 5 years in sterile pharmaceutical manufacturing and cleanroom environments preferred.
• Practical knowledge of execution of routine maintenance and calibration activities in a GMP Sterile Fill Facility.
• Proficiency in Microsoft Office and job-related computer applications.

Desirable

• SME in Electrical & Instrumentation / Mechanical production systems.
• Lean Six Sigma methodology experience.
• Proficient with CMMS/CCMS management tools and technical documentation in a validated environment.
• Solid understanding of GMP validation data integrity and regulatory expectations for calibration and maintenance.
• Demonstrated troubleshooting skills and cross-functional collaboration.
• Capable to lead multi disciplined teams in an individual contributor capacity.

Our Commitment to Ireland:

Our Company Ireland is one of the Irelands leading healthcare companies having first established here over 50 years ago. We have a dynamic and diverse team of over 3000 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 companys top products helping save and enhance lives in over 140 countries around the world.

The Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines biologics and small molecule drug its initial launch the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities laboratories and temperature-controlled warehousing units. The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the worlds 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 worlds 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:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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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.

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Relocation:

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