Computer System CSV Support Specialist

Computer System CSV Support Specialist ROCGJP00027575

A leading biotechnology company is looking for a Computer System Support Specialist to work at their highly automated pharmaceutical drug substance facility, which employs highly integrated computer control systems to manage plant operations and manufacturing data. The candidate will report to the local Manufacturing IT OT organization (currently undergoing a transformation towards digitalization) and support system maintenance, development, testing, and the like.

Computer System CSV Support Specialist Pay and Benefits:

• Hourly pay: $60-$75/hr
• Worksite: Leading biotechnology company (Hillsboro, OR 97124 - Onsite)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• 40 hours/week, 12 month assignment

Computer System CSV Support Specialist Responsibilities:

• Be actively involved 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.
• 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, eVal Roche).
• Support the team with administrative tasks

Computer System CSV Support Specialist Qualifications:

• Bachelor’s degree in Computer Engineering, Automation Engineering or similar.
• 5+ years of experience in system and/or network administration.
• 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.
• Network administration experience.
• Experience with industrial data and control interfaces, preferably OPC and OPC-UA.
• System administration experience, supporting multiple platforms and applications.
• Ability to 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".