IT Platform Owner - Medical Device Manufacturing at Lubrizol
Wickliffe, OH 44092, USA -
Full Time


Start Date

Immediate

Expiry Date

14 Oct, 25

Salary

0.0

Posted On

14 Jul, 25

Experience

3 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Training Programs, It, Data Analytics, Maintenance, Analytical Skills, Manufacturing Systems, Oracle Scm, Regulatory Requirements, Contract Manufacturing, Crm, Optimization, Availability, Product Lifecycle Management, Platform Architecture, Documentation, Data Integrity

Industry

Pharmaceuticals

Description

JOIN OUR THRIVING TEAM AT LUBRIZOL AS AN IT PLATFORM OWNER - MEDICAL DEVICE MANUFACTURING

Unleash Your Potential. At Lubrizol, we’re transforming the chemical industry and looking for exceptional talent to join us on this journey. If you are ready to join an international company with talent around the world and want to make a real impact, we want you on our team.

SKILLS THAT MAKE A DIFFERENCE:

  • Bachelor’s degree in Information Technology, Computer Science, Engineering, or a related field.
  • Minimum of 7+ years of experience in IT, with at least 3-5 years in a platform ownership, system administration, or business systems analyst role focused on manufacturing environments.
  • Proven experience with core manufacturing IT systems such as MES, QMS, and ERP (e.g., SAP PP/QM, Oracle SCM, Infor, Epicor).
  • Demonstrable experience working in a manufacturing environment, with a strong understanding of shop floor processes, production control, quality assurance, and supply chain management.
  • Specific experience in the medical device manufacturing industry is required, including familiarity with relevant regulatory requirements (FDA 21 CFR Part 11, Part 820, ISO 13485).
  • Experience with contract manufacturing (CMO/CDMO) models and the associated IT integration and data exchange challenges.
  • Strong understanding of system validation processes (IQ/OQ/PQ) within a regulated environment.
  • Excellent project management, problem-solving, and analytical skills.
  • Strong communication, interpersonal, and leadership skills, with the ability to collaborate effectively with technical and non-technical stakeholders.
  • Ability to manage multiple priorities in a fast-paced environment
  • Ability to travel 10% of the time
Responsibilities

As an IT Platform Owner - Medical Device Manufacturing, you’ll be at the forefront of our innovation, leading the lifecycle management, optimization, and governance of our critical manufacturing IT platforms. You’ll collaborate with a diverse group of passionate individuals to deliver sustainable solutions to advance mobility, improve wellbeing and enhance modern life. This role is pivotal in ensuring our manufacturing operations, including those involving contract manufacturing partners and medical device production, are supported by robust, compliant, and efficient technology solutions. The ideal candidate will possess a strong background in IT platform management, a deep understanding of manufacturing processes (shop floor systems, MES, QMS, ERP integration), and specific experience within the medical device industry’s regulatory landscape.

  • Develop and maintain the strategic roadmap for assigned manufacturing IT platforms (e.g., Manufacturing Execution Systems (MES), Quality Management Systems (QMS), Product Lifecycle Management (PLM), ERP modules related to manufacturing, SCADA/IIoT platforms).
  • Oversee the entire lifecycle of the platform, from requirements gathering, selection, implementation, and upgrades, through to maintenance, optimization, and eventual decommissioning.
  • Act as the primary IT liaison for manufacturing, quality, engineering, and supply chain departments. Collaborate closely with business stakeholders to understand their needs, gather requirements, and ensure platform alignment with business objectives.
  • Manage relationships with software vendors and service providers, including contract manufacturers, ensuring service level agreements (SLAs) are met and solutions are delivered effectively.
  • Ensure seamless integration of manufacturing platforms with other enterprise systems (e.g., ERP, CRM, LIMS) to enable efficient data flow and business processes.
  • Ensure manufacturing IT platforms adhere to relevant medical device regulations (e.g., FDA 21 CFR Part 11, Part 820, ISO 13485, GxP).
  • Lead and/or support validation activities (IQ, OQ, PQ) for manufacturing systems, including documentation and execution.
  • Oversee change control processes for validated systems.
  • Monitor platform performance, availability, and reliability. Identify and implement improvements to enhance system stability and user experience.
  • Implement and maintain security best practices for manufacturing platforms, ensuring data integrity and protection against cyber threats.
  • Provide oversight for user support and develop/deliver training programs to ensure effective utilization of the platforms.
  • Drive continuous improvement initiatives for manufacturing IT platforms, leveraging data analytics and industry best practices to optimize processes and reduce costs.
  • Contribute to budget planning and manage expenditures related to the assigned platforms.
  • Ensure comprehensive documentation of platform architecture, configurations, processes, and procedures
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