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Automation/IT compliance professional with 12+ years of experience in manufacturing IT/OT looking to grow in the traditional IT realm. Experienced in providing end user support for automation/IT computer systems and equipment in an FDA regulated cGMP environment.
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It Compliance AnalystNovo Nordisk Aug 2024 - PresentBagsværd, Dk• Improve our capability to provide quality to all IT & automation processes by analyzing & improving the levels of compliance (Project management, Quality programs)• Ensure IT data systems are available, capable & accessible so that IT systems operate at the speed of business processes through quality initiatives & projects (ARE Management, business continuity & IT support)• Recommend & implement quality initiatives to meet the customer’s needs, regulatory & internal compliance & add value to all business processes• Become subject-matter expert (SME) with NN validation software, eTIMs, within the IT team• Project management – develop & utilize skills necessary to develop, manage & implement IT projects of all sizes (small to large scale projects)• Follow all safety & environmental requirements in the performance of duties• Manage change requests & system validation for IT• Serve as IT lead for audits• Site Data Integrity Steward• Coordinate with QA Compliance Specialists to assure compliance with procedures & policies• Support & practice IT Security• Follow all safety & environmental requirements in the performance of duties• Comply with internal & external regulations & procedures• Follow all safety and environmental requirements in the performance of duties• Other duties as assigned -
It System Manager I - OfpNovo Nordisk Apr 2023 - Aug 2024Bagsværd, Dk• Ensure system compliance with internal SOPs & guidelines as well as external requirements (21CFR Part 11, Personal Data Protection, SARBOX, etc.)• Manage/maintain system lifecycle documentation• Review & maintain all IT CSV validation/system decommissioning documentation• Document operation & maintenance of the system (incident management, contract/SLA management, data integrity/retention/archive, continuity/recovery plans)• Perform system assessments & reviews to ensure basic IT controls are in place & in control to ensure compliance/security of the system• Review and ensure appropriate testing (i.e., FAT, SAT, UAT, IQ, OQ, PQ, PV, & Commissioning) to ensure IT requirements are met• Participate in root cause analysis for deviations within supported IT systems to ensure effective corrective actions are identified & implemented• Manage NN Global IT inspections and audits• Maintain ServiceNow registrations• Work with subject matter expert (SME) to ensure system documentation is compliant with local, corporate & regulatory regulations• Work with IT Security/SME to ensure controls are in place & documented• Review/approve IT periodic system evaluations• Site Data Integrity Steward -
Automation Systems AdministratorEli Lilly And Company Jul 2021 - Mar 2023Indianapolis, Indiana, Us• Partner with Corporate Automation, Automation Integrators, and Global Facilities delivery to design, install, and qualify the site Rockwell based FactoryTalk View HMI/SCADA Platforms, Lilly’s OT/IT integration layer, and end-point cyber security solutions.• System Administration ownership of these platforms post-delivery including user access controls, life cycle management, process improvements, data management, and system maintenance.• Manage and own the system security including data integrity.• Perform audits and periodic assessments of the systems to ensure compliance with Global Quality and Engineering Standards.• Lead the management and growth of the platforms and support of manufacturing process teams as new systems are added to the facility.• Partner with Corporate Automation, Information Technology, and Information Security for global initiatives and life cycle management.• Be a champion for site safety activities, diversity/inclusion, ethics, and compliance. -
Senior Specialist, Manufacturing AutomationMerck Feb 2020 - Jul 2021• Provide technical leadership for assigned area and systems to ensure a compliant and reliable supply of product and on time project execution with production shop floor support as needed.• Application of sound project management techniques to meet schedule, budget, benefit realization and other project objectives.• Provide direct support for regulatory inspections and audits and other validation activities by serving as the subject matter expert.• Provide technical guidance/support including authoring or review and approval of automation incidents, Quality Notifications, system commissioning and qualification, change control, and other key automation related processes.• Assist in the development and review and approval of department SOPs and other site GMP SOPs related to automation and digital activities and adheres to established quality standards.• Support problem solving practices to identify and resolve technical and operational problems.
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Sr. Automation EngineerBiomérieux Apr 2017 - Jan 2020Marcy-L'Étoile, Auvergne-Rhône-Alpes, Fr• Provide support as a subject matter expert to maintain automation systems in a compliant and fit for intended use state.• Conduct Failure Investigations and implement solutions (corrective and preventive actions) that solve automation problems, follow-up on corrective and preventive actions to determine their effectiveness and suitability, and prepare written reports on these activities in a timely fashion.• Lead small projects and make independent decisions on automation problems.• Participate in commissioning and qualification activities (e.g. SAT, IQ, OQ) and conduct verification activities as required by the change control program.• Analyze computerized systems performance data to identify trends to predict potential failures and aid in solving product and process problems.• Review and revise Manufacturing and Engineering documents for new and existing automated manufacturing systems.• Provide and document training of technical and production personnel in the application of new automated manufacturing systems. -
Automation EngineerBiomérieux Mar 2015 - Apr 2017Marcy-L'Étoile, Auvergne-Rhône-Alpes, Fr -
Associate Automation EngineerBiomérieux Apr 2014 - Mar 2015Marcy-L'Étoile, Auvergne-Rhône-Alpes, Fr -
Controls EngineerCummins Inc. Feb 2012 - Apr 2014Columbus, Indiana, Us• Maintain and continuously improve plant process control systems, plant production network and data collection.• Modify software and equipment to ensure that sensors and actuators are functioning according to specifications.• Assist with the development, design, and implementation of control systems and bench tests.• Program and interface with PLCs and HMI software packages (Allen Bradley).• Investigate problems and requirements of projects while developing plans for solutions in line with economic, personnel, and environmental considerations• Provide support for the maintenance and production activities and debug basic problems and change requests.• Assist with the preparation of cost estimates, compile required cost and equipment information, and draft appropriation request.• Utilize statistical process control to maintain capability of assigned machines. -
Manufacturing Engineering InternCummins Inc. May 2010 - Aug 2010Columbus, Indiana, Us -
Controls InternCummins Inc. May 2009 - Aug 2009Columbus, Indiana, Us
Malcolm Stewart Skills
Malcolm Stewart Education Details
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North Carolina Agricultural And Technical State UniversityElectrical Engineering -
Uniondale High School
Frequently Asked Questions about Malcolm Stewart
What company does Malcolm Stewart work for?
Malcolm Stewart works for Novo Nordisk
What is Malcolm Stewart's role at the current company?
Malcolm Stewart's current role is IT Compliance Analyst at Novo Nordisk.
What is Malcolm Stewart's email address?
Malcolm Stewart's email address is ma****@****ail.com
What is Malcolm Stewart's direct phone number?
Malcolm Stewart's direct phone number is +151690*****
What schools did Malcolm Stewart attend?
Malcolm Stewart attended North Carolina Agricultural And Technical State University, Uniondale High School.
What skills is Malcolm Stewart known for?
Malcolm Stewart has skills like Control Logic, Control Systems Design, Troubleshooting, Spc, Root Cause Analysis, Allen Bradley, Process Control, Validation, Gmp, Manufacturing, Factorytalk View, Controllogix.
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