Computer Systems Validation

4 weeks ago

Hillsboro, United States Tailored Management Full time

Job Title: Computer Systems Validation Support

Job Location: 4625 NE Brookwood Parkway, Hillsboro, OR 97124

Duration: 16+ months contract with possibility of extension based on the business need


About the Role:

Join our highly automated pharmaceutical drug substance facility in Hillsboro, Oregon, and play a key role in advancing our digital transformation. As part of the local IT OT organization, you will support Hillsboro Technical Operations (HTO) and Hillsboro Individualized and Cell Therapies (HIT). Your work will be crucial in managing our plant operations and manufacturing data through highly integrated computer control systems.


Responsibilities:

  • Actively support daily operations for all Manufacturing IT OT systems.
  • Assist IT OT System owners with system lifecycle tasks including maintenance, validation, documentation, and testing.
  • Update system lifecycle documentation for IT OT systems (DeltaV, PI, MES, SCADA, LyoPLus, FIT, BAS, WAGIT).
  • Conduct system maintenance activities and periodic reviews, including data collection and impact assessment on validated states.
  • Attend coordination meetings to stay updated on changes to global IT systems affecting IT OT systems.
  • Support System Owner squad in the procurement, development, integration, operation, maintenance, and retirement of IT OT systems.
  • Perform validation activities, including generating, approving, and executing validation protocols.
  • Assist with user account auditing, provisioning, resets, and activation for IT and OT systems.
  • Create on-demand reports and manage ServiceNow tickets.
  • Support document management systems (Veeva, Condor, eVal).
  • Handle various administrative tasks as needed.


Minimum Requirements:

  • Bachelor’s degree in Computer Engineering, Automation Engineering, or a related field.
  • Minimum 5 years of experience in system and/or network administration.
  • Strong management and problem-solving skills.
  • Ability to interact productively with stakeholders from different technical domains.
  • Experience in biopharmaceutical or similar manufacturing environments is preferred.


Technical Skills:

  • Proficient in System and Network Administration.
  • Knowledge of industrial data and control interfaces (preferably OPC and OPC-UA).
  • Experience with validation of computerized systems.
  • Familiarity with GMP, Health Authority practices, 21 CFR Part 11, cGMP Annex 11, and Data Integrity principles.
  • Awareness of trends in Smart Buildings, Smart Manufacturing, Industrial IoT, Cybersecurity, and Pharma 4.0.


Competencies:

  • Detail-oriented with excellent problem-solving abilities.
  • Strong communication skills and the ability to work under pressure in a fast-paced environment.
  • Motivated, independent, and a good team player.


Why Join Us?

Be part of a forward-thinking team driving digital transformation in pharmaceutical manufacturing. This role offers opportunities for growth and the chance to work with cutting-edge technologies in a dynamic and supportive environment.


How to Apply:

If you meet the qualifications and are excited about this opportunity, we encourage you to apply. Please submit your resume and cover letter highlighting your relevant experience and skills.

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