Validation Engineer - CSV

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Company: Katalyst HealthCares and Life Sciences

Location: Hillsboro, OR 97124

Description:

Responsibilities:
  • Work to support the ITOT System owners in tasks associated with the lifecycle of the system, ie. maintenance, validation, documentation, testing.
  • Update System lifecycle documentation, as the need arises, for ITOT systems (DeltaV, PI, MES, SCADA, LyoPLus, FIT, Client, WAGIT).
  • Help perform MILE (system maintenance) activities for ITOT Systems.
  • 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.
  • Attend coordination meetings with different groups within the organization to keep up with 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 Roche).
  • 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 calm behavior and work under pressure in a fast-paced environment.
  • Good team player, self-confident, motivated, and independent.
  • Good communication skills.

Technical 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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