Computer System CSV Support

7 days ago

Hillsboro, United States Avispa Technology Full time
Computer System CSV Support ROCGJP A leading biotechnology company is seeking a Computer System CSV Support.

The successful candidate will support the organization that is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as standardizing and leveraging new technologies.

The ideal candidate has 5+ years of experience in system and/or network administration.

Computer System CSV Support Pay and Benefits:

Hourly pay:
$75-$85/hr (Pay varies based on candidate's experience)

Worksite:
Leading biotechnology company (Hillsboro, OR W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL 40 hours/week, 18 Month Assignment Computer System CSV

Support 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, BAS, 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 years worth of planned and unplanned events, review impact on systems 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 and others). Support the team with administrative tasks.

Computer System CSV Support Qualifications:
5+ years of experience in system and/or network administration. Minimum Bachelors degree in Computer Engineering, Automation Engineering or similar. 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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