Computer System Support Specialist

7 days ago

Hillsboro, United States Avispa Technology Full time

Job Summary

Avispa Technology is seeking a highly skilled Computer System Support Specialist to join our team. As a key member of our ITOT team, you will be responsible for providing technical support and maintenance for our manufacturing IT systems.

Key Responsibilities

  • Provide technical support and maintenance for manufacturing IT systems, including system maintenance, validation, documentation, and testing.
  • Update system lifecycle documentation as needed.
  • Perform system periodic reviews, including data collection, review of impact on 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 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 Roche).

Requirements

  • Bachelor's degree in Computer Engineering, Automation Engineering, or similar.
  • 5+ years of experience in system and/or network administration.
  • 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.
  • Network administration experience.
  • Experience with industrial data and control interfaces, preferably OPC and OPC-UA.
  • System administration experience, 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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