Spclst, Engineering

Job Description

An amazing opportunity has arisen for a Spclst Engineering.

We are hiring an Instrumentation Engineer (SME) to oversee site-wide calibration and gas detection this role you will manage CMMS and calibration data (ProCal or similar) maintain contract governance and oversight with our outsourced provider support audits and serve as the subject matter expert during regulatory inspections.

You will engage with and support local and global initiatives across EHS Quality Maintenance and Engineering. You will uphold data integrity ensure validated documentation standards and contribute to reliability engineering efforts.

You build strong relationships across Production Quality EHS and Engineering delegate effectively within project teams and balance people and business needs across programs and projects.

What you will do:

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

• System Owner of site calibration program for both instrumentation and gas detection systems.
• Be responsible for all aspects of the instrumentation and gas detection equipment installed on site eg: Lead RCAs quality deviations Instrumentation performance reviews.
• Provide engineering support to both maintenance and equipment owners.
• Ensure maintenance program is appropriate for reliable operation of equipment.
• Support and/or lead instrument and equipment criticality assessments in line with GMP and risk-based approaches.
• Ensure calibration strategies align with criticality risk and validation status.
• Maintain criticality documentation and ensure alignment with site procedures.
• Maintain and optimise the CMMS and CCMS configurations (asset hierarchy PM libraries workflows) and ensure clean reconciled reports.
• Master data accuracy (FLOCS/assets BOMs spare parts vendor records PMs) ensuring maintenance records are auditable and ALCOA compliant.
• Create and maintain workorder & calibration impact matrices; develop CMMS workflows to prevent closeout without required attachments and approvals.
• 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 role based dashboards and reports covering maintenance performance workorder status PM compliance.
• 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 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.
• Drive and participate effectively in writing/revising/rolling out accurate operational procedures training materials and maintenance procedures for various systems.
• 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 on site.
• 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:

• Bachelors degree in manufacturing/mechanical/electrical/Instrumentation Engineering.
• Minimum 5 years in pharmaceutical manufacturing preferred.
• Solid understanding of GMP validation data integrity and regulatory expectations for calibration and maintenance.
• Proficient with CMMS/CCMS management tools and technical documentation in a validated environment.
• Lean Six Sigma methodology experience.
• Demonstrated troubleshooting skills and cross-functional collaboration.
• The desire to continuously learn improve and develop.
• Willingness to support the team and a strong focus on delivering excellence.
• Demonstrating energy and enthusiasm the engineer will be a role model for operational excellence and will contribute to the organisations overall capability to thrive and grow.
• Proven track-record in delivering results in a world-class supply organisation.
• Practical knowledge of execution of routine maintenance and calibration activities in a GMP Sterile Fill Facility.
• Experience of working in a cross functional environment.

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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