[얀센백신] Execution Systems Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in pharmaceutical, medical devices and diagnostics markets, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. 
Learn more at https://www.jnj.com/.

1. 포지션: Execution Systems Engineer
2. 계열사: 얀센백신
3. 근무지: 인천 연수구
4. 근무 형태: Regular

[Summary]

Johnson and Johnson Innovative Medicine Supply Chain is recruiting for an Engineer, Execution Systems, Incheon Site, Large Molecule Platform.  This position must be based at an active Johnson and Johnson Innovative Medicine, Incheon (Janssen Vaccines) site.

The Execution Systems is a dedicated team focused on implementing a standard recipe-based product management processes across all the sectors in Johnson & Johnson. This will deliver the following:

1. Consistent content management

2. Optimized execution end to end

3. Proactive visualization of a preferred future for execution

The Execution Systems is managing all of the systems in MTO (Manufacturing Technology and Operation) including Process Control system, Building Management System, Environmental Management System, Utility Management System, Automation Integration layer, PI system.

The Engineer will report to the Execution Systems Site lead. The Position at site level will be responsible for implementing, supporting and maintaining the ISA-95 level 1, 2 and 3 systems. Site ES engineer will execute all the activities required to ensure that computerized systems are fit for intended use and compliant with applicable regulations throughout the entire system life cycle Site ES engineer will be responsible to maintain and update local recipe element (process content, technology process actions and phases, libraries) and CSV & Data Integrity as Manufacturing System Administrator and maintain Network and Virtual machine server that possess L2 Systems.

[Main responsibilities]

PROJECT LEADERSHIP

·        Project leadership of ES projects, including obtaining agreement on project definitions and priorities and ensuring that resources, capabilities and processes are in place.

·        Acts as project leader/core team members by tracking cost, quality and schedule ensuring an effective management of project execution

·        Ensures programs stay on plan by resolving resource conflicts and removing obstacles, which may involve negotiations at a senior level within the business and Execution Systems COE.

·        Establishes effective working relationships with Quality, IT, Lab Systems, Procurement, PDMS departments and others as well as develops new partnerships to optimize processes.

·        Ensures sound technical engineering concepts are applied in all tasks.

·        Develop a mechanism to proactively assess business needs and to identify points of leverage across functional groups in the LM Platform

TECHNICAL RESPONSIBILITIES

Site : The position is responsible for the following site specific tasks:

·        System Administrator for Execution systems

·        Maintain Computerized Systems Validation & Data Integrity Status for Execution systems

·        Maintain Data integrity of MTO Execution systems

·        Management of Creation of Master Recipe within the Execution systems

·        Recipe management work

·        Support Execution Systems related (legacy) systems

·        Configure and manage system interfaces

·        Daily Operation Support

·        Conduct local ES system data performance monitoring

·        Ensure site compliance and adherence with global/ platform standards

·        Feedback site needs and priorities to Global enterprise through Platform governance

·        Write and execute validation protocol - CSV

·        24/7 system support (local execution, with option to elevate to Global platform level)

·        Execute against global SOPs (including back up, disaster recovery, user administration etc.) and manage site specific work instructions

·        Participate in compliance inspections for topics related to ES systems

·        Implement & maintain Server and network  (in partnership with IT)

·        Providing (User) training to end users and system admins

·        Provide user defined reports and facilitate ad-hoc queries

·        Execute risk assessments

·        Execute ES related projects

·        Create and maintain lifecycle documentation management for applications

·        Create Functional Specification and Design Specification

·        Conduct module testing, Functional Acceptance Test (FAT) and Site Acceptance Test (SAT)

·        Conduct Integration testing (IQ) and Functional testing (OQ) of CSV

·        Support and participate in investigations (Events/CAPA's) for deviations related to ES systems

·        Manage Sub-contractor

·         

·        ORGANIZATIONAL LEADERSHIP

·        Capable of working in a matrix organization for engineers at platform or enterprise level.

·        Collaboration and partnership with the various internal and external partners like Quality, IT, Lab Systems, Technical Operations, PDMS, Production and others as well as collaboration with General Managers

·        Ensure compliance in all aspects of Environmental, Health, Safety and Sustainability (EHSS) per Johnson & Johnson standards.

[Qualifications:]

·        A technical education / degree in industrial automation, information technology or relevant engineering discipline is required. 

·        Experience delivering innovative technical and engineering solutions in multiple manufacturing environments is preferred

o    Siemens PLC (S7-300/400)

o    PLC Configuration using STEP 7 / TIA Potal

o    Siemens Win CC

o    Siemens Desigo CC

o    Wonderware Intouch HMI

o    Windows SQL

o    AVEVA PI

o    PAS-X MES

o    VM Ware

o    CISCO Network Switch

·        Experience in GMP or GLP regulated environment and a related position is preferred

o   minimum of 2-5 years experience is preferred

·        Knowledge of Process Excellence tools (Lean, Six Sigma) preferred.  Green or Black Belt Certification in Lean or Six Sigma is preferred. 

·        Knowledge of technology development and validation, including design of experiments and statistical analysis, is preferred. 

·        Execution systems engineers on platform and enterprise level require the following additional capabilities:

o   A minimum of a Bachelor's degree in Engineering

o   Must have the ability to assess and mitigate technical risks. 

o   Project leadership experience is preferred. 

o   Familiarity with IT application design and deployment is required. 

o   Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) is required. 

o   Excellent verbal and written English communications skills

o   Strong decision making and problem solving skills

o   Must have the ability to think strategically and manage change. 

o   The ability to collaborate effectively with all levels of management and drive alignment in a global environment is required.

o   must demonstrate strong cross-functional business acumen, as well as the experience in information technology deployment

[JD 확인 및 지원 방법]
www.careerhub.jnj.com -> Requisition number “2406179788W”검색 -> 해당 모집 공고 클릭 후, “Apply Now”

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