Computer System Support Specialist

1 week ago

Hillsboro, United States Apollo Professional Solutions Full time
Job Title: Computer System CSV Support

This is a unique opportunity to join Apollo Professional Solutions, a leading provider of professional services, as a Computer System CSV Support specialist. In this role, you will be responsible for providing technical support and maintenance for computerized systems used in pharmaceutical manufacturing.

Key Responsibilities:
  • Active involvement in the daily operations of manufacturing IT systems to support system owners and ensure smooth production.
  • Support the team in manufacturing site projects and with various administrative tasks and validation activities.
  • 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 with changes to global IT systems that may affect ITOT systems.
  • Support system owners 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 and user account auditing, provisioning, resets, and activation for all IT and OT systems.
  • Creating reports for various systems on demand and working with system owners and business process owners for upgrade/patching and changes to the system to ensure GMP compliance.
  • Review ServiceNow tickets and either address them or route them to the SME.
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 detail, 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".

Apollo Professional Solutions is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.

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