Computer Systems Engineer

19 hours ago

Hillsboro, United States MindSource Full time
About the Role

We are seeking a highly skilled Computer Systems Engineer to join our team at MindSource.

This is a unique opportunity to work on the daily operations of Manufacturing IT OT systems, supporting system owners and collaborating with the team on manufacturing site projects and administrative tasks.

Key Responsibilities
  • Active involvement in the daily operations of Manufacturing IT OT systems to support system owners.
  • Support the team in manufacturing site projects and various administrative tasks.
  • Work with ITOT System owners on tasks associated with the lifecycle of the system, including maintenance, validation, documentation, and testing.
  • Update System lifecycle documentation for ITOT systems.
  • Perform system periodic reviews, including data collection, review of impact on the system's validated state, and drafting reports.
  • Attend coordination meetings with different groups within the organization to stay up-to-date on changes to global IT systems that may affect ITOT Systems.
  • Support System Owner squad in the overall procurement, development, integration, modification, operation, maintenance, and retirement of ITOT systems.
  • Support validation activities, generation, approval, and execution of validation protocols.
  • Assist System Owners in the Periodic System Audit Trail Review.
  • User account auditing, provisioning, resets, and activation for all IT and OT systems.
  • Creating reports for various systems on demand.
  • Work with the System Owners and Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance.
  • Review ServiceNow tickets and either address them or route them to the SME.
  • Support on documents management systems (Veeva, Condor, eVal).
  • Support the team with administrative tasks.
Requirements
  • Minimum Bachelor's degree in Computer Engineering, Automation Engineering, or similar.
  • Minimum 5 years of experience in system and/or network administration.
  • Management skills.
  • Attention to details and good problem-solving skills.
  • Demonstrated ability to think and solve problems at a system-level.
  • Ability to work and interact productively with stakeholders from different technical domains.
  • Ability to multi-task with a calm behavior and work under pressure in a fast-paced environment.
  • Good team player, self-confident, motivated, and independent.
  • Good communication skills.
  • System Administration.
  • Network Administration.
  • Experience with industrial data and control interfaces, preferably OPC and OPC-UA.
  • System administration, supporting multiple platforms and applications.
  • Ability to create and execute validation on computerized systems.
  • Biopharmaceutical or similar Manufacturing domain knowledge.
  • Application Engineering experience with manufacturing control systems in a highly automated manufacturing environment.
  • Keep abreast of key Manufacturing IT trends and be curious - Smart Buildings, Smart Manufacturing, Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, technology, and data standardization, etc.
  • Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11, cGMP Annex 11, Data Integrity principles.
  • Entrepreneurial mindset e.g. 'automating automation'.

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