Job Description

Mission

Sanofi is preparing its future through an ambitious program named EVolutive Facility (EVF). The EVF Project is at the cornerstone of Sanofi Pasteur 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 business challenges. Digital will be one of the key topics to help EVF to reach its ambition. On top of it, Sanofi is also embarked with the ambition to leapfrog the competition through a digital acceleration program with the following vision: \xe2\x80\x9cSanofi will fully integrate Digital capabilities & culture within its operations to boost business growth and profitability in 2025+\xe2\x80\x9d

The EVF Sr. Automation engineer is a mid-carrier individual contribution role expected to work with multiple stake holders to establish end to end (Design, Implement, Validate and Operate) innovative automation solutions and align with Manufacturing 4.0 initiatives.

This key new role will coordinate with EVF Manufacturing and EVF MTECH(MS&T) process design leader to implement the latest Automation technologies on the new paradigms of single use-based processes.

The mission\xe2\x80\x99s scope requires a high interactive collaboration with the various best in class Automation solution providers, consultants, and external skid vendors.

The Evolutive Facility Sr. Automation Engineer will report to Evolutive Facility Automation Lead.

Key accountabilities

Project Requirements

• Lead and contribute to capital projects involving facilities, utilities, equipment, and system integration in automation aspects.
• Review the Vendor functional specifications and ensure the user requirements are met.
• Manage the Automation Vendors and ensure the requirements are delivered and maintained.
• Implement the best possible solutions keeping the controller, server memory intact.
• Propose and implement the best practices for the detailed design of the automation systems implementation for Production and Utilities
• Drive the commissioning and qualification effort of the Production equipment\xe2\x80\x99s with associated automation.
• Study and propose modifications to equipment, processes, and operations to improve safety, increase efficiency and enhance company goals (more complex, with minimal guidance)
• Develop specifications for process equipment and assist in FAT / SAT of related equipment as part of the Automation scope boundary.
• Scope preparation for assigned projects from medium to large scale.
• Develop project budget, procurement, and scheduling preparation & progress reporting for medium to large scale projects.
• Managing and communicating to stakeholders of small to medium scale projects with minimal guidance
• Perform, coordinate project execution, test commissioning, validation coordination for medium to large scale projects and handover with minimal guidance.
• Establish communication with MES for driving the Process recipes and ensuring the related interfaces with the Automation systems are properly configured.
• Drive execution on the systems within its responsibility from basic engineering down to non-product dependent performance qualification.
• Ensure the hardware design and Infrastructure is done as par the industry regulatory and latest digital standards.
• Manage the cybersecurity requirements and work closely with digital team to implement a safe working environment free from cyber threats.
• Implement the fully digitalized plant to achieve Sanofi Digital ambition.
• Any other responsibilities or tasks as assigned by your Supervisor/Manager

Operational requirements

• Support the development of production recipes and devising automation solutions that improve productivity, business operations and safety/quality standards.
• Troubleshoot automation system and its interfaced systems related issues in manufacturing operations.
• Ensure the reliability and performance of automation system, proactively address potential safety and quality issues, regularly review, and address frequent occurring alarms.
• Participate or lead quality or safety investigations and implement any automation solutions resultant from these investigations.
• Monitor and maintain automation systems and ensure system operations are optimized.
• Ensure periodic preventive maintenance of automation systems are carried out and perform periodic review of automation systems.
• Develop, revise, and review SOPs as needed. Ensure the automation systems compliance up-keep.
• Participate in Regulatory audits and assist the Compliance team in the audit requirements.
• Audit and update existing system documentation and procedures.
• Complete all automation systems training and ensure the external staff training records are up to date with respect to compliance requirements.
• Provide Automation Systems training to end users on process automation.
• Provide technical guidance to Engineers and ensure the training records are kept up to date.

Accountability

• Safety, Design, quality, on time completion within budget for the assigned packages.
• Report the predefine KPI to management for implementing automation system for the project.
• Accountable for planning and role out of Automation SOPs for Operations in alignment with Company\xe2\x80\x99s internal and external regulatory policies and guidelines.

Education and Experience

• Preferred: Masters in Automation related Specialization or bachelor\xe2\x80\x99s degree in Electrical/Electronics and Communication/ Instrumentation/ Chemical Engineering.
• Industrial experience in the Bio pharmaceutical/Vaccines/API business or equivalent

Preferred 8-10 years in Automation and Control systems, Projects, and Operations

• Good technical knowledge coupled with hands-on working experience in Bio/pharmaceutical/ vaccines plant engineering services.
• Experience in Greenfield projects is most preferable
• Experience in Automation systems (Siemens PLC\xe2\x80\x99s most preferred)
• Knowledge and experience in DeltaV will be added advantage
• Good to have knowledge about Historian (OSIPI or IP21) and its related interfaces
• Must possess Knowledge of implementing the infrastructure (VMWare, Hyper-V) and must have experience with Industrial networks (Control networks, Profinet and Bus related technologies)
• Knowledge about MES (OpCenter, Syncade or equivalent) and its corresponding interfaces with the automation systems.
• Working experience in start-ups, commissioning & qualification (CSV) of Automation and process control systems in an operating plant, including Process HAZOP, HAZID, FMEA and product tech transfer.
• Individual lead contribution in a small to medium scale project execution track record.
• Working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards
• Good knowledge in pharmaceutical regulatory market requirements and experience in participation of Audits. Eg;- FDA, EMA, HSA & etc.,
• Knowledge in Singapore local statutory regulatory requirements, code of practices related to process industry projects.
• Good knowledge in project procurement to handle vendor & subcontract management, RFQ, tender review, technical and commercial bid analysis report for the projects proposed.
• Knowledge in project finance for budgeting, cost management & control, ROI, report preparation for medium to large-scale capital projects.

Skills Required

• Principles of automation, automatic control systems and automatic manufacturing technologies
• Types and features of automated equipment used in a biopharmaceuticals manufacturing facility
• Manufacturing process steps and Fundamental concepts of software programming
• Types and characteristics of automation input devices
• Interpretation of electrical symbols and schematic diagrams
• Innovation management
• Principles of electrical networking
• Current Good Manufacturing Practices (CGMPs)
• Excellent analytical, strategic vision, and operational mindset
• Project ownership and decision-making skills
• Good communication skills and ability to influence and develop external partnerships
• Project scheduling & reporting skills
• Technical report writing
• Ability to lead contingent staffs, external resources, including vendors & contractors
• Good team player willing to work for the common goal.
• Openness to learn and adopt with new environment
• Ability to Lead & manage FastTrack ERP role out projects.
• Big data analysis and Process optimization

Key Stakeholders

• EHS, Manufacturing, Process Engineering, Quality, MTech, Procurement, Digital.
• Global Engineering Technical Services
• EPCM service providers, Vendors & Contractors.
• Automation Solution providers

PROJECT & ROUTINE PHASE

#

Task / Duties / Responsibilities

Weightage

(Equals 100%)

1. Detailed design of Production equipment automation, Review and Approval - 30%

2. Contract and Change management - 10%

3. Vendor FAT - 15%

4. Start-Up and C&Q management - 30%

5. Transversal team coordination and task implementation - 15%

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Sanofi