Computer System CSV Support ROCGJP00026362 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 97124) • 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 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 and others). • Support the team with administrative tasks. Computer System CSV Support Qualifications: • 5+ years of experience in system and/or network administration. • Minimum Bachelor’s 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".