Computer System CSV Support Specialist

4 days ago

Hillsboro, United States Mindlance Full time
Job Description

Onsite in Hillsboro, OR, we are seeking a highly skilled Computer System CSV Support Specialist to join our team at Mindlance.

About the Role

This position provides the opportunity to have a key role in a highly automated pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations and manufacturing data. The candidate will report to the local IT OT organization, an organization that is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as standardizing and leveraging new technologies.

The IT OT Team in Hillsboro is supporting Hillsboro Technical Operations (HTO) which is the commercial Aseptic filling for Drug Product and launch site for North America and Hillsboro Individualized and Cell Therapies (HIT) which is transitioning into a multi-product facility for development, clinical and commercial supply capabilities for individualized and cell therapies.

Key Responsibilities
  1. Active involvement in the daily operations for all Manufacturing IT OT systems to support the system owners for all Manufacturing systems and supporting the team in manufacturing site projects and with various administrative tasks and validation activities.
  2. Work to support the ITOT System owners in tasks associated with the lifecycle of the system, ie. maintenance, validation, documentation, testing.
  3. Update System lifecycle documentation, as the need arises, for ITOT systems (DeltaV, PI, MES, SCADA, LyoPLus, FIT, Client, WAGIT).
  4. Help perform MILE (system maintenance) activities for ITOT Systems.
  5. Perform system periodic reviews- This entails performing data collection from the deviations database on the past 3 year's worth of planned and unplanned events, review impact on system's validated state and draft reports.
  6. Attend coordination meetings with different groups within the organization to keep up with changes to global IT systems that may affect ITOT Systems.
  7. Support System Owner squad in the overall procurement, development, integration, modification, operation, maintenance, and retirement of ITOT systems.
  8. Support validation activities, generation, approval and execution of validation protocols.
  9. Assist System Owners in the Periodic System Audit Trail Review.
  10. User account auditing, provisioning, resets and activation for all IT and OT systems.
  11. Creating reports for various systems on demand.
  12. Work with the System Owners and Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance.
  13. Review ServiceNow tickets and either address them or route them to the SME.
  14. Support on documents management systems (Veeva, Condor, eVal Roche).
  15. 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 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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