Senior Engineer I, Reliability (EVF)

Purpose:

Vaccines M&S is preparing its future through an ambitious program named Evolutive Facility (EVF). The EVF Project is at the cornerstone of Sanofi strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable, and agile, leveraging new disruptive technologies, to better address vaccine business challenges.
She/He responsible for increasing system reliability, sustainability, and maintainability of the entire GMP and Non GMP systems. Includes, performs detailed engineering design, maintenance and operation support for systems, Active support for the new installation, continue improvement and troubleshooting of existing systems.
The Senior Engineer 1, Reliability (EVF) will report to Equipment & Facilities Manager.

1. Maintenance excellence execution, review and approve

• Development of FMECA as a knowledge platform for plant-specific risk assessment, reliability-enhancing activities, and determination of plant maintenance strategies.
• Reviewing, monitoring, and ensuring compliance requirements are met for design (e.g., Standards, specification and local codes and regulations etc.).
• Perform periodic analysis on equipment database to determine improvement priorities; increase equipment uptime and reduce asset ownership costs.
• Originate and develop analysis methods for determining reliability of components, equipment, and processes.
• Routinely audit the operational performance and regulatory compliance of large number of highly complex equipment components or systems.
• Manage Predictive Maintenance (PDM) programs (e.g., vibration, infra-red, motor circuit analysis, ultrasonics, etc.); poses ability to understand the data output and make informed decisions on how to prioritize the corrective work from these PDM programs.

2. Maintenance, Contract and Change management

• Strong knowledge in project procurement to handle vendor & subcontract management, RFQ, tender review, technical and commercial bid analysis report for the projects proposed.
• Good knowledge of Total Productive Maintenance (TPM), apply and implement to plant maintenance program to improve equipment reliability and performance.
• Ensure all maintenance activities are meticulously documented to demonstrate compliance with regulatory requirements (e.g., cGMP - Current Good Manufacturing Practices).
• Implement measures to ensure data integrity, such as secure storage of maintenance data and audit trail features.

3. System Reliability follow up

• Support Plan and execute scheduled maintenance activities to prevent failures.
• Ensuring assigned CAPA/deviation/CCR/DCR tasks are managed and resolved in a timely manner.
• Routinely audit the operational performance and regulatory compliance of large number of highly complex equipment components or systems.
• Originate and develop analysis methods for determining reliability of components, equipment, and processes.
• Lead actions/projects to improve, modify or replace equipment identified as “bad actors”.
• Perform work within budget and schedule parameters and provide appropriate feedback to project manager for workload, schedule and cost management.
• Perform and/or facilitate on-site startup and training activities.
• Prepare for audits by conducting thorough self-assessments and mock audits to identify and rectify any potential compliance issues in advance. During audits, the Reliability engineer may serve as a subject matter expert (SME) for all maintenance and equipment -related matters.

4. Support Start-Up and C&Q management

• Support and participate in commissioning & qualification of related systems in an operating plant, including related HAZOP, HAZID, FMEA, SOP, CMMS, maintenance procedures and regulation requirements.
• Support to prepare the C&Q related documents like URS, DR, FCCA, SIA.
• Participate in system startup, shake down, pre startup check and commissioning of the engineering and process systems.
• Review and update the operation support documents like SOP, PM plan, Training matrix.

5. Coordination with other functions

• Perform/lead investigations and root cause analysis of repetitive problems and investigate equipment failures as part of deviation investigation and CAPA.
• Utilize quality systems to ensure compliance with regulatory requirements.
• Comply with requirements from Sanofi Safety Program including Health and Safety regulations and OSHA requirements.
• Coordinate with manufacturing and maintenance planner to establish the detailed maintenance plan for the site with out impact on production schedule.

Knowledge, Skills & Competencies / Language

• Knowledge of regulatory requirements, including FDA, EMA, HSA regulations and cGMP.
• Knowledge of relevant software tools and programming languages is beneficial.
• Proficiency in maintenance and reliability systems, including design, installation, testing, and troubleshooting.
• Excellent verbal and written communication skills for interacting with internal teams, clients, and stakeholders.
• Strong analytical and problem-solving skills to diagnose complex technical issues and implement effective solutions.
• Familiarity with relevant industry codes, standards, and safety regulations
• Project ownership and decision-making skills
• Project scheduling & reporting skills
• Ability to lead contingent staffs, external resources, including vendors & contractors.
• Good team player willing to work for the common goal.

Qualifications / Requirement

• Related Engineering Degree from an accredited technical institution.
• Minimum 8 years’ experience in maintenance management and reliability engineering, preferably with plant operations in engineering field, preferably with pharmaceutical manufacturing and/or petrochemical plant experience.
• Preferred with certification in reliability professional.
• 5 years' experience in reliability engineering tools such as FMEA, RCM, MTBF, Life-Cycle costing, Pareto, and Root Cause Failure Analysis.
• Other requirements of the job
• Familiarity with SAP computerized maintenance management systems is advantageous.
• Certification in calibration or a related field is desirable.

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